Irritable Bowel Syndrome (IBS)GIANTNCT06681012
Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome
A study testing Gelsectan® in people with Irritable Bowel Syndrome (IBS) and Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by Devintec Sagl at 12 sites in 4 countries.
Trial summary
Irritable Bowel Syndrome (IBS) is one of the major Disorders of Gut-Brain Interaction (DGBI) and the most frequent reasons for referral to both primary care providers and gastroenterologists.IBS is not a life-threatening disease, but imposes a significant burden on society, entailing a decrease in patients' Quality of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
- What is being tested?
- Gelsectan®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 22 Oct 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥18 years and ≤ 65 years.
- Positive diagnosis of IBS, according to Rome IV diagnostic criteria, namely recurrent abdominal pain, on average, at least 1 day/week in the last 3 months associated with two or more of the following criteria:
- related to defecation
- associated with a change in frequency stool
- associated with a change in form (appearance) of stool The above criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
- Positive diagnosis of IBS-D subtype based on Rome IV diagnostic criteria, i.e., more than 25% of bowel movements with a consistency of type 6 or type 7 (loose or watery stools) on the BSFS, and less than 25% of bowel movements with BSFS types 1 or 2 (hard or lumpy stools), on days with at least one abnormal bowel movement.
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- Negative results to any relevant additional tests or exams whenever deemed appropriate by the Investigator to exclude other disorders or causes of IBS symptoms.
- At least one type 6 or type 7 bowel movement based on the BSFS on at least 4 days within the last week prior to randomization.
- Weekly average score of 24-hours worst abdominal pain score ≥ 3 on NRS-11 in the last week prior to randomization.
- Electronic diary (e-diary) completed on at least 11 of 14 days (≥ 75%) during the screening period (i.e., 2 weeks prior to randomization).
- Willingness and capability to fulfil all tasks foreseen by the Clinical Investigation Plan (CIP).
- Signed written informed consent.
- Females of childbearing potential must have a negative urine pregnancy test (dipstick) at randomization and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective or acceptable effective contraceptive method for the individual subject and her partner(s) throughout the study treatment period and for at least one full contraceptive cycle (when applicable).
Who cannot join
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiovascular, renal, neurological, endocrine, metabolic or hepatic disease) that would preclude participation in this study in the opinion of the Investigator, or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
- Known perforation and/or gastrointestinal obstruction.
- Ascertained organic gastrointestinal diseases, including celiac disease, bile acid malabsorption or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.
- Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed unless within six months prior to screening).
- Active malignancy of any type (except for non-invasive basal or squamous cell carcinoma of the skin), or history of a malignancy other than non-invasive basal or squamous cell carcinoma of the skin. Patients with a history of malignancies that have been surgically removed with no evidence of recurrence for at least five years and no treatment prior to screening are allowed to participate in the study.
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- History of allergy or hypersensitivity to any of the investigational product ingredients or excipients.
- Current use of Gelsectan®.
- Use of loperamide or antispasmodics (i.e., direct smooth muscle relaxants, anticholinergic agents and calcium channel blockers) in the 14 days prior to randomization.
- Concomitant use (starting from screening) of weak and potent opioids, 5-HT3 antagonists, such as alosetron and ondansetron, bile acid sequestrants, eluxadoline or any other drug/supplement known to significantly interfere with abdominal pain, stool frequency and consistency and/or intestinal permeability (except for those allowed as rescue therapy starting from randomization), including but not limited to corticosteroids, aminosalicylates, immunosuppressants and biologicals.
- Prior and concomitant use of probiotics/prebiotics/synbiotics or rifaximin starting from 28 days prior to randomization. Other oral antibiotics and topical antibiotics are allowed.
- Any major psychiatric unstable disorder, including eating disorders, and use of antidepressant or anxiolytic agents, unless used at a stable dose for at least 6 weeks prior to randomization.
- History or current evidence of laxative abuse within 5 years prior to screening.
- Recent history (within 12 months prior to screening) or suspicion of alcohol abuse or drug addiction.
- Treatment with any investigational drug or medical device within 30 days prior to randomization, or current participation in other clinical trials or investigations.
- Pregnancy or breastfeeding or intention to look for pregnancy throughout the whole study duration.
Trial locations and contacts
12 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 4 countries
Italy7 sites, 7 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola
Bologna, BO, 40138
Giovanni Barbara
- Recruiting
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, 20122
Maurizio Vecchi
- Recruiting
AOU Federico II di Napoli
Naples, 80131
Giovanni Sarnelli
- Recruiting
Azienda Ospedale Università Padova
Padova, 35128
Edoardo Vincenzo Savarino
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Michele Di Stefano
- Recruiting
Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, 56124
Massimo Bellini
- Recruiting
S. Andrea University Hospital
Roma, 00189
Bruno Annibale
France2 sites, 2 recruiting
- Recruiting
Hôpital Avicenne
Bobigny, 93000
Jean Marc Sabaté
- Recruiting
CHU de Rouen
Rouen, 76000
Chloè Melchior
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Vall d´Hebron
Barcelona, 08035
Javier Santos
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Carlos Teruel Sanchez-Vegazo
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven (UZ Leuven)
Leuven, 3000
Jan Tack
About this study
Official title: Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome: a Multicentre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study
Irritable Bowel Syndrome (IBS) is one of the major Disorders of Gut-Brain Interaction (DGBI) and the most frequent reasons for referral to both primary care providers and gastroenterologists.IBS is not a life-threatening disease, but imposes a significant burden on society, entailing a decrease in patients' Quality of Life (QoL), elevated rates of psychological comorbidities and loss of work productivity, which might be the greatest in subjects with IBS-D, for whom the fear of incontinence in a social situation can be especially debilitating. Moreover, IBS is associated with significant direct and indirect healthcare costs and has a considerable socioeconomic impact on society.
Treatment strategy for IBS is usually based on predominant symptoms and their severity, and requires a strong patient-physician relationship, as well as both non-pharmacological and pharmacological approaches. Lifestyle interventions, such as dietary modifications, physical activity and lifestyle adjustments, and stress reduction/psychological therapy represent the most important initial non-pharmacological clinical approach for IBS patients, especially for those with mild disease. First-line pharmacological options for IBS-D include antidiarrheals, mainly loperamide, to control diarrhoea, as well as antispasmodic drugs to relieve IBS symptoms, in particular abdominal pain. Second-line therapies indicated for the treatment of global IBS-D symptoms include rifaximin, 5-Hydroxytryptamine (5-HT)3 receptor antagonists (alosetron, ondansetron and ramosetron) and eluxadoline. Other treatments recommended in patients with IBS-D consist of Tricyclic Anti-Depressants (TCAs) and bile acid sequestrants.
Read more
Notably, management of patients with IBS is challenging since diagnosis and treatment could require several therapeutical strategies with often partial and unsatisfactory results. Indeed, most patients with IBS are dissatisfied with their current therapy and 34% report no symptom control, according to the IBS Global Impact Report of 2018.
At present, there is a growing interest in therapeutic approaches for IBS-D aimed at improving intestinal barrier integrity for a more efficient control of symptoms, considering that an intestinal epithelial barrier dysfunction and mucosal immune activation have been suggested as a central mechanism in IBS-D pathophysiology. In this perspective, film-forming agents capable of protecting the intestinal mucosal barrier, such as Xyloglucan (XG) and Pea protein may represent a valid alternative therapeutic option for the management of IBS-D.
Gelsectan® is a CE-marked medical device under the European Union (EU) Medical Device Regulation (MDR) 2017/745, whose classification under the MDR is class III. Gelsectan® contains XG, Pea protein, grape seed extract, and Xylo-Oligosaccharides (XOS) and is indicated for symptomatic relief and prevention of chronic or relapsing diarrhoea, abdominal tension, pain, bloating and flatulence, as well as protection and restoration of intestinal mucosal function. Based on previous non-clinical studies and two clinical investigations, Gelsectan® seems to be safe and exert a protective action on the intestinal mucosa, mediating the restoration of intestinal permeability and the improvement of gastrointestinal symptoms associated with IBS-D. In particular, a 28-day treatment with Gelsectan® significantly reduced IBS-D-associated diarrhoea, abdominal pain and bloating, with no related adverse events in a randomized, placebo-controlled, cross-over clinical study. Moreover, Gelsectan® treatment for 6 months was generally safe and effective in improving IBS severity, diarrhoea and bowel habit, as well as pain and bloating, in a recent multicentre, open-label, prospective, observational study. Of note, Gelsectan® was also mentioned in the recent clinical practice guidelines on IBS-D and functional diarrhoea of the United European Gastroenterology (UEG) and the European Society for Neurogastroenterology and Motility (ESNM), and a recent consensus on IBS conducted by a panel of Belgian gastroenterologists.
With these premises, the present study aims to further assess the performance and safety of Gelsectan® within the scope of its intended purpose, compared with placebo, on overall abdominal pain and symptoms in patients with IBS-D in a randomized, double-blind, parallel-group clinical study.
- Being tested
- Gelsectan®, Placebo
- Keywords
- Gelsectan, Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome of Diarrhea type (IBS-D)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelsectan®Device
Oral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment).
PlaceboDrug
Oral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment).
| Study group | Role | What they receive |
|---|---|---|
| Gelsectan® | Experimental | Gelsectan® is a class III CE-marked medical device under the Regulation (EU) 2017/745 (MDR), which has been present on the EU market since 2017. Gelsectan® medical device consists of non-sterile capsules containing film-forming compounds (Xyloglucan, Pea protein, grape seed extract, and Xylo-oligosaccharide) indicated for symptomatic relief and prevention of IBS symptoms. Receives: Device: Gelsectan® |
| Placebo | Placebo comparator | Placebo capsule, comparable in size, appearance and taste, packaging and labelling, as well as mode and schedule of administration to the IMD (i.e., Gelsectan®). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Gelsectan® on the composite response rate for abdominal pain and stool consistency over the 8-week treatment period, at the end of treatment, in patients with IBS-D, according to Rome IV criteria.
Proportion of composite responders over 8 weeks determined at the End of Treatment.
A composite responder is defined as a patient who meet the following criteria for at least 50% of the 8-week treatment period:
- Pain response criteria: reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline, measured with the 11-point Numeric Rating Scale (from 0=none to 10=worst possible pain) AND
- Stool consistency response criteria: reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline, measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces).
A patient needs to fulfil both aforementioned response criteria for abdominal pain and stool consistency in the same week to be considered a responder for that week.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (27)
Effect of Gelsectan® on overall IBS-D symptoms: composite response rate for abdominal pain and stool consistency over 4-week intervals
Proportion of composite responders over each 4-week intervals.
A composite responder is defined as a patient who meet the following criteria for at least 50% of the 8-week treatment period:
- Pain response criteria: reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline, measured with the 11-point Numeric Rating Scale (from 0=none to 10=worst possible pain) AND
- Stool consistency response criteria: reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline, measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces).
A patient needs to fulfil both aforementioned response criteria for abdominal pain and stool consistency in the same week to be considered a responder for that week.
Measured: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of pain responders
Proportion of pain responders, defined as patients who meet the pain response criteria (i.e., reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline) for at least 50% of the observation period.
The standard 11-point Numeric Rating Scale (NRS-11) (from 0=none to 10=worst possible pain imaginable) will be used for the measure of pain.
Measured: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of stool consistency responders
Proportion of stool consistency responders, defined as patients who meet the stool consistency response criteria (i.e., reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline) for at least 50% of the observation period.
Stool consistency will be measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces).
Measured: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Mean 24-hour worst abdominal pain score
Mean 24-hour worst abdominal pain score, as self-assessed by patients daily up to Week 12 using the Numeric Rating Scale (NRS-11) (from 0=none to 10=worst possible pain imaginable)
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean stool type
Mean number of days/week with a BSFS type ≤ 2, ≥ 3 and ≤ 5, and ≥ 6, as well as changes from baseline, as self-assessed by patients daily up to Week 12 through the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces).
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean number of stools/day
Mean number of stools/day (average daily frequency of defecation)
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean weekly average score for bloating
Mean weekly average score for bloating, as self-assessed by patients using a 7-point Likert scale (ranging from 0 to 6, where 0= not bad/bothersome at all and 6= extremely bad/bothersome)
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean weekly average score for urgency of defecation
Mean weekly average score for urgency of defecation, as self-assessed by patients weekly using a 7-point Likert scale (ranging from 0 to 6, where 0= no urgency at all and 6= a very great deal of urgency)
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on IBS symptom severity: Proportion of patients with global improvement of IBS
Proportion of patients with global improvement of IBS, defined as a score of at least 4 on the IBS Global Assessment of Improvement (IBS-GAI).
IBS-GAI score ranging from 0 to 6 (where 0 = "substantially worse", 1 = "moderately worse", 2 = "slightly worse", 3 = "unchanged", 4 = "slightly improved", 5 = "moderately improved", and 6 = "substantially improved").
Measured: From enrollment to the end of treatment at 8 weeks and after 4-week post-treatment period
Effect of Gelsectan® on IBS symptom severity measured by the IBS-Symptom Severity Scale score
Change from baseline in IBS severity, as measured by the IBS-Symptom Severity Scale (IBS-SSS) score.
IBS-SSS is a validated five-item questionnaire measuring the frequency and intensity of abdominal pain, the severity of abdominal distension, the dissatisfaction with bowel habits, and the interference of IBS with daily life. Each item is rated from 0 to 100, with a total score ranging from 0 to 500, with higher scores indicating a greater severity. Severity of IBS can be graded as mild (<175), moderate (175-300), or severe (>300) based on the IBS-SSS total score.
Measured: From enrollment to the end of treatment at 8 weeks and after 4-week post-treatment period
Effect of Gelsectan® on work productivity and activity impairment due to IBS
Change from baseline of work productivity and activity impairment due to IBS, as measured by the Work Productivity and Activity Impairment (WPAI):IBS questionnaire scores.
WPAI:IBS is a validated questionnaire consisting of six items intended to assess work productivity and daily activity impairment due to IBS in the preceding 7 days (Visual Analogue Scale [VAS] from 0 to 10) and daily activity impairment resulting from IBS (VAS from 0 to 10).
WPAI:IBS scores are represented as percentages (range of 0-100%), with higher percentages indicating a greater work productivity loss and daily activity impairment.
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on quality of life as measured by World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Change from baseline of patient QoL, as measured by World Health Organization Quality of Life Brief Version (WHOQOL-BREF).
The WHOQOL-BREF questionnaire is a validated measurement of QoL consisting of an abbreviated, 26-item version of the 100-item WHOQOL-100 QoL measure. The WHOQOL-BREF addresses four QoL domains, i.e., physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items), with each item graded on a 5-point Likert scale. Each domain score is calculated by multiplying by a factor of four the mean of all item scores. Domain scores are then transformed to a 0-100 scale, with higher scores indicating a better QoL.
Measured: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on depression symptoms
Change from baseline of symptoms of depression, as measured by the Patient Health Questionnaire (PHQ)-9 score.
PHQ-9 is a nine-item questionnaire assessing depression symptoms according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in the past two weeks, with each item score ranging from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score is representative of depression severity and ranges from 0 to 27, by which depression is defined as mild (5-9), moderate (10-14), moderate (15-19) or severe (more than 20).
Measured: From enrollment to the end of the 12 weeks study period
Use of rescue therapy
Use of rescue therapy (type and posology) during treatment
Measured: From enrollment to the end of treatment at 8 weeks
Healthcare utilization
Incidence of visits to patient's General Practitioner (GP), Emergency Room (ER) visits and unplanned hospitalizations (with length of stay)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: adverse events and device deficiencies
Incidence and type of all adverse events and device deficiencies throughout the study
Measured: From enrollment to the end of treatment at 8 weeks
Safety: changes in systolic and diastolic Blood Pressure
Changes in systolic and diastolic Blood Pressure (mmHG)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: changes in Heart Rate
Changes in Heart Rate (bpm)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in Respiratory Rate
Changes in Respiratory Rate (breaths per minute)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in the concentration of Glucose, Blood Urea Nitrogen (BUN), bilirubin, creatinine
Changes in the concentration of Glucose, Blood Urea Nitrogen (BUN), bilirubin, creatinine (mg/dl)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in the concentration of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase
Changes in the concentration of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase (U/L)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in White Blood Cell count, Platelet count, Red Blood Cell count
Changes in White Blood Cell count, Platelet count, Red Blood Cell count
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in haemoglobin concentration
Changes in haemoglobin (g/dl) concentration
Measured: From enrollment to the end of treatment at 8 weeks
Safety: Changes in haematocrit
Changes in haematocrit (%)
Measured: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine specific gravity
Changes in urine specific gravity
Measured: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine pH
Changes in urine pH
Measured: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine protein, glucose, bilirubin, ketones, blood concentrations
Changes in urine protein, glucose, bilirubin, ketones, blood concentrations (mg/dl)
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start22 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devintec Sagl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681012
- Sponsor's protocol ID
- DVT2024
- Acronym
- GIANT
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome: a Multicentre, Randomized, Double-blind, Parallel-group, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06681012
- Acronym / sponsor ID
- GIANT / DVT2024
- Keywords
- Gelsectan, Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome of Diarrhea type (IBS-D)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Devintec SaglIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable Bowel Syndrome (IBS) is one of the major Disorders of Gut-Brain Interaction (DGBI) and the most frequent reasons for referral to both primary care providers and gastroenterologists.IBS is not a life-threatening disease, but imposes a significant burden on society, entailing a decrease in patients' Quality of Life (QoL), elevated rates of psychological comorbidities and loss of work productivity, which might be the greatest in subjects with IBS-D, for whom the fear of incontinence in a social situation can be especially debilitating. Moreover, IBS is associated with significant direct and indirect healthcare costs and has a considerable socioeconomic impact on society.
Treatment strategy for IBS is usually based on predominant symptoms and their severity, and requires a strong patient-physician relationship, as well as both non-pharmacological and pharmacological approaches. Lifestyle interventions, such as dietary modifications, physical activity and lifestyle adjustments, and stress reduction/psychological therapy represent the most important initial non-pharmacological clinical approach for IBS patients, especially for those with mild disease. First-line pharmacological options for IBS-D include antidiarrheals, mainly loperamide, to control diarrhoea, as well as antispasmodic drugs to relieve IBS symptoms, in particular abdominal pain. Second-line therapies indicated for the treatment of global IBS-D symptoms include rifaximin, 5-Hydroxytryptamine (5-HT)3 receptor antagonists (alosetron, ondansetron and ramosetron) and eluxadoline. Other treatments recommended in patients with IBS-D consist of Tricyclic Anti-Depressants (TCAs) and bile acid sequestrants.
Notably, management of patients with IBS is challenging since diagnosis and treatment could require several therapeutical strategies with often partial and unsatisfactory results. Indeed, most patients with IBS are dissatisfied with their current therapy and 34% report no symptom control, according to the IBS Global Impact Report of 2018.
At present, there is a growing interest in therapeutic approaches for IBS-D aimed at improving intestinal barrier integrity for a more efficient control of symptoms, considering that an intestinal epithelial barrier dysfunction and mucosal immune activation have been suggested as a central mechanism in IBS-D pathophysiology. In this perspective, film-forming agents capable of protecting the intestinal mucosal barrier, such as Xyloglucan (XG) and Pea protein may represent a valid alternative therapeutic option for the management of IBS-D.
Gelsectan® is a CE-marked medical device under the European Union (EU) Medical Device Regulation (MDR) 2017/745, whose classification under the MDR is class III. Gelsectan® contains XG, Pea protein, grape seed extract, and Xylo-Oligosaccharides (XOS) and is indicated for symptomatic relief and prevention of chronic or relapsing diarrhoea, abdominal tension, pain, bloating and flatulence, as well as protection and restoration of intestinal mucosal function. Based on previous non-clinical studies and two clinical investigations, Gelsectan® seems to be safe and exert a protective action on the intestinal mucosa, mediating the restoration of intestinal permeability and the improvement of gastrointestinal symptoms associated with IBS-D. In particular, a 28-day treatment with Gelsectan® significantly reduced IBS-D-associated diarrhoea, abdominal pain and bloating, with no related adverse events in a randomized, placebo-controlled, cross-over clinical study. Moreover, Gelsectan® treatment for 6 months was generally safe and effective in improving IBS severity, diarrhoea and bowel habit, as well as pain and bloating, in a recent multicentre, open-label, prospective, observational study. Of note, Gelsectan® was also mentioned in the recent clinical practice guidelines on IBS-D and functional diarrhoea of the United European Gastroenterology (UEG) and the European Society for Neurogastroenterology and Motility (ESNM), and a recent consensus on IBS conducted by a panel of Belgian gastroenterologists.
With these premises, the present study aims to further assess the performance and safety of Gelsectan® within the scope of its intended purpose, compared with placebo, on overall abdominal pain and symptoms in patients with IBS-D in a randomized, double-blind, parallel-group clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelsectan® | Experimental | Device: Gelsectan®Gelsectan® is a class III CE-marked medical device under the Regulation (EU) 2017/745 (MDR), which has been present on the EU market since 2017. Gelsectan® medical device consists of non-sterile capsules containing film-forming compounds (Xyloglucan, Pea protein, grape seed extract, and Xylo-oligosaccharide) indicated for symptomatic relief and prevention of IBS symptoms. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule, comparable in size, appearance and taste, packaging and labelling, as well as mode and schedule of administration to the IMD (i.e., Gelsectan®). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, age ≥18 years and ≤ 65 years.
- Positive diagnosis of IBS, according to Rome IV diagnostic criteria, namely recurrent abdominal pain, on average, at least 1 day/week in the last 3 months associated with two or more of the following criteria:
- Positive diagnosis of IBS-D subtype based on Rome IV diagnostic criteria, i.e., more than 25% of bowel movements with a consistency of type 6 or type 7 (loose or watery stools) on the BSFS, and less than 25% of bowel movements with BSFS types 1 or 2 (hard or lumpy stools), on days with at least one abnormal bowel movement.
- Negative results to any relevant additional tests or exams whenever deemed appropriate by the Investigator to exclude other disorders or causes of IBS symptoms.
- At least one type 6 or type 7 bowel movement based on the BSFS on at least 4 days within the last week prior to randomization.
Key exclusion criteria (16 listed)
- Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiovascular, renal, neurological, endocrine, metabolic or hepatic disease) that would preclude participation in this study in the opinion of the Investigator, or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values.
- Known perforation and/or gastrointestinal obstruction.
- Ascertained organic gastrointestinal diseases, including celiac disease, bile acid malabsorption or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- Presence of other intestinal motility disorders, such as biliary dyskinesia, gastroparesis, intestinal pseudo-obstruction, and narcotic bowel syndrome.
- Previous major abdominal surgery (uncomplicated appendectomy, cholecystectomy, polypectomy, inguinal hernia surgery, or caesarean section are allowed unless within six months prior to screening).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelsectan®Oral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment). | Device | Gelsectan® |
| PlaceboOral capsules are to be taken twice a day for 2 months (two capsules in the morning before breakfast and two capsules in the evening before dinner during the first 4 weeks of treatment; one capsule in the morning and one in the evening during the following 4 weeks of treatment). | Drug | Placebo |
Primary outcome
Effect of Gelsectan® on the composite response rate for abdominal pain and stool consistency over the 8-week treatment period, at the end of treatment, in patients with IBS-D, according to Rome IV criteria.
Time frame: From enrollment to the end of treatment at 8 weeks
Proportion of composite responders over 8 weeks determined at the End of Treatment. A composite responder is defined as a patient who meet the following criteria for at least 50% of the 8-week treatment period: * Pain response criteria: reduction of at least 30% in the weekly average score of the 24-hour worst abdominal pain compared with baseline, measured with the 11-point Numeric Rating Scale (from 0=none to 10=worst possible pain) AND * Stool consistency response criteria: reduction of at least 50% in the number of days per week with at least one stool that has a consistency of BSFS types 6 or 7 compared with baseline, measured daily using the Bristol Stool Form Scale - BSFS (from 1=separate hard lumps, like nuts to 7=watery, no solid pieces). A patient needs to fulfil both aforementioned response criteria for abdominal pain and stool consistency in the same week to be considered a responder for that week.
27 secondary outcomes
Effect of Gelsectan® on overall IBS-D symptoms: composite response rate for abdominal pain and stool consistency over 4-week intervals
Time frame: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of pain responders
Time frame: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Proportion of stool consistency responders
Time frame: From enrollment to the end of treatment at 8 weeks and each 4-week interval, as well as the 4-week post-treatment period
Effect of Gelsectan® on overall IBS-D symptoms: Mean 24-hour worst abdominal pain score
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean stool type
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean number of stools/day
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean weekly average score for bloating
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on overall IBS-D symptoms: Mean weekly average score for urgency of defecation
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on IBS symptom severity: Proportion of patients with global improvement of IBS
Time frame: From enrollment to the end of treatment at 8 weeks and after 4-week post-treatment period
Effect of Gelsectan® on IBS symptom severity measured by the IBS-Symptom Severity Scale score
Time frame: From enrollment to the end of treatment at 8 weeks and after 4-week post-treatment period
Effect of Gelsectan® on work productivity and activity impairment due to IBS
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on quality of life as measured by World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
Time frame: From enrollment to the end of the 12 weeks study period
Effect of Gelsectan® on depression symptoms
Time frame: From enrollment to the end of the 12 weeks study period
Use of rescue therapy
Time frame: From enrollment to the end of treatment at 8 weeks
Healthcare utilization
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: adverse events and device deficiencies
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: changes in systolic and diastolic Blood Pressure
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: changes in Heart Rate
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in Respiratory Rate
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in the concentration of Glucose, Blood Urea Nitrogen (BUN), bilirubin, creatinine
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in the concentration of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in White Blood Cell count, Platelet count, Red Blood Cell count
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in haemoglobin concentration
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: Changes in haematocrit
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine specific gravity
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine pH
Time frame: From enrollment to the end of treatment at 8 weeks
Safety: changes in urine protein, glucose, bilirubin, ketones, blood concentrations
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelsectan® in people with Irritable Bowel Syndrome (IBS) and Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by Devintec Sagl at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Dini (+39 3383236335, maria.dini@prineos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Gelsectan® on the composite response rate for abdominal pain and stool consistency over the 8-week treatment period, at the end of treatment, in patients with IBS-D, according to Rome IV criteria. (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.