Irritable Bowel Syndrome With Diarrhea (IBS-D)NCT04138186
G-PUR® for Symptomatic Treatment in Irritable Bowel Syndrome With Diarrhea
A study testing 2.0g G-PUR®, oral administration in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Glock Health, Science and Research GmbH at 1 site in Austria.
Trial summary
A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea (IBS-D)
- What is being tested?
- 2.0g G-PUR®, oral administration
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 2 Oct 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Recurrent abdominal pain, at least one day/week in the last 3 months (with symptom onset at least 6 months before diagnosis), associated with two or more of the following criteria (Rome IV criteria)
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form (appearance) of stool.
- Moderate to severe abdominal pain as defined with an IBS Symptoms Severity Scale (IBS-SSS) score > 175
Show all 12Show fewer
- Patient reports that abnormal bowel movements are usually diarrhea with more than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2. Starting during the screening/run-in phase, all patients will keep diaries of stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997)
- Stable eating habits, within one month before randomization
- In patients > 50 years colonoscopy performed during the past 5 years demonstrates no pathology associated with the symptoms reported for IBS
- Ability to understand trial instructions and to comply with treatment
- Patient agree to be compliant for study interactive web - response system schedule confirmed at time of randomization
- Written informed consent prior to enrolment
Who cannot join
- Patient has exclusively constipation-predominant IBS (IBS-C) that is characterized by < 3 bowel movements/week or hard and lumpy stools (e.g. Bristol stool form types 1 or 2)
- Patient has irritable bowel syndrome with mixed bowel habits (IBS-M) with varying symptoms of constipation and diarrhea
- Calprotectin stool value > 200mg/kg stool
- Known hypersensitivity to the IMD (known aluminium and/or silicon hypersensitivity)
- Patient has failed to record >50% of daily diary entries during run-in period
- Rectal bleeding in the absence of documented bleeding hemorrhoids or anal fissures assessed by fecal occult blood test
Show all 24Show fewer
- History of major gastric, hepatic, pancreatic or intestinal surgery or perforation with exception of appendectomy, cholecystectomy and inguinal hernia
- Patients with a history of positive tests for ova, parasites or clostridium difficile must undergo repeat testing, which must be negative, during the screening period
- Use of the following prohibited medications: any antibiotics including rifaximin within the past 2 months or during treatment period, use of cholestyramine during entire study period, during run-in phase and during the treatment period any use of concomitant medication effecting the gastrointestinal movement and/or function (e.g. anticholinergic drugs, 5-HT3 receptor antagonists, prokinetic agents, intestinal flora regulating drugs, parasympathetic inhibitors, opioids or eluxadoline)
- Use of immunosuppressive drugs within the last 6 months or planned use of immunosuppressive drugs during the study
- Patients treated with tricyclic antidepressants
- Serotonin re-uptake inhibitors are allowed if the patient is at stable dose for at least 8 weeks prior to signing informed consent and the dose will remain stable throughout the duration of the study.
- History of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis) and celiac disease (by anamnesis and assessed by tTGA levels)
- Active infection, or abnormalities in laboratory testing, vital signs, or physical examination at screening
- Participation in any other interventional clinical trial within 4 weeks before study participation
- Alcohol or drug abuse (History of alcohol abuse or heavy alcohol use as binge drinking on 5 or more days per month within the 12 months prior to screening. Known medication and drug abuse)
- Pregnant or breastfeeding (for all females, negative pregnancy test at screening and at each treatment visit will be performed).
- History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study
- Patients with known familial colorectal cancer syndromes, where colorectal cancer has not been excluded by colonoscopy
- Other severe comorbid condition, concurrent medication, or other issue that renders the patient unsuitable for participation in the study, including but not limited to: comorbid condition with an estimated life expectancy of ≤ 12 months, patients with uncontrolled hypothyroidism, uncontrolled hyperthyroidism, patients on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA III and IV, uncontrolled hypertension systolic BP by repeated measurement > 180 mmHg; patient with uncontrolled diabetes with an Hba1c >6.5%)
- Concomitant psychotherapy is allowed if the patient started therapy for at least 8 weeks prior to signing informed consent and the schedule will remain stable throughout the duration of the study.
- Known severe psychiatric disorders or mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study;
- Presence of any condition that impacts compliance with the study procedures
- Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
Michael Wolzt, Prof. Dr., +43 (0)1 40400 ext. 2981, michael.wolzt@meduniwien.ac.at
Michael Wolzt, Prof. Dr.
About this study
Official title: A Randomized, Placebo Controlled, Double-blind, Parallel-arm Feasibility (Pilot) Study to Evaluate Safety and Clinical Efficacy of G-PUR® Treatment in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks.
- Being tested
- 2.0g G-PUR®, oral administration, Placebo, oral administration
- Keywords
- IBS, Diarrhea, Gastrointestinal function disorder
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.0g G-PUR®, oral administrationDevice
tid for 12 weeks
Placebo, oral administrationDevice
tid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2.0g G-PUR® capsules | Experimental | Not described Receives: Device: 2.0g G-PUR®, oral administration |
| Placebo capsules | Placebo comparator | Not described Receives: Device: Placebo, oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of responders for the patient's global assessment of relief using the last four assessments in the treatment period.
Measured: 12 weeks
Secondary outcomes (24)
Patient's global assessment of symptom relief measured on a 5-point Likert scale (1= very good and 5= very poor)
Measured: 12 weeks
Incidence of adverse (and serious) events
Measured: 12 weeks
Daily intensity of bloating using a 11-point numerical rating scale (NRS) where 0 represents no bloating discomfort and 10 represents very severe bloating discomfort
Measured: 12 weeks
Daily urgency using a 11-point numerical rating scale (NRS) where 0 represents no defecation urgency and 10 represents worst imaginable urgency
Measured: 12 weeks
Daily stool frequency
Daily Stool Frequency assessed by daily diary entry of the total number of bowel movements within the last 24 hours
Measured: 12 weeks
Patient compliance with daily diary reporting
Measured: 12 weeks
ePRO usability using a paper questionnaire
Measured: 12 weeks
Worst daily abdominal pain using a 11-point NRS
Percentage of responders, defined as the percentage of participants who meet the following criterion for at least 50% of the days with diary entry: Abdominal pain assessed by a 11-point NRS-scale improved at least 30% compared to baseline
Measured: 12 weeks
Daily stool consistency using the Bristol Stool Form Scale (Type 1 separate hard lumps, like nuts (hard to pass); Type 7 watery, no solid pieces, entirely liquid)
Percentage of responders, defined as the percentage of participants who have ≥50% reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared to baseline
Measured: 12 weeks
Responder rate (ie weekly and daily) of the combined endpoint: worst daily abdominal pain and daily stool consistency
Measured: 12 weeks
Additional responder analyses (i.e. weekly and daily) of IBS symptoms listed all above evaluating different change in symptom intensity with treatment (i.e., greater than or equal to 30, 40 and 50 percent change in intensity compared with baseline)
Measured: 12 weeks
Number of pain-free days
Measured: 12 weeks
Assessment of gastrointestinal symptoms using the IBS-SSS during each onsite visit;
Proportion of patients having a reduction ≥ 50 on the IBS-SSS system (ranges 0-500). A decrease in 50 or greater in the IBS-SSS is considered a positive response.
Measured: 12 weeks
Quality of Life using validated generic SF12 questionnaire
Measured: 12 weeks
Hospital anxiety and depression scale (HADS)
scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression
Measured: 12 weeks
Stress response using the perceived stress questionnaire
The (Perceived Stress Questionnaire) PSQ consists of 30 items, each of which has to be scored by a test person using a Likert scale (1 for "almost never", 2 for "sometimes", 3 for "frequently" to 4 for "mostly") how often each item/sentence applied during the last month. Each number has a point that reveals the level of stress for each sentence. Points are calculated according to the calculation system of the scale, and for each individual, the final calculation results in the total value between 0 and 100. Higher total values indicate more stress
Measured: 12 weeks
Use of rescue medication (to be assessed daily)
Measured: 12 weeks
Exploratory endpoint: bile acid in stool
bile acid excretion in stool before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: zonulin in stool
zonulin (ng/ml) in stool before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: microbiome in stool
microbiome in stool assessed by 16S gene sequencing before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: HBD2 in stool
human beta defensin 2 (HBD2) (ng/ml) in stool before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: gluten in stool
gluten (ng/ml) in stool before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: IDO in blood
indoleamine-2,3- dioxygenase (IDO) (umol/mmol) in capillary blood before and after 12 weeks treatment
Measured: 12 weeks
Exploratory endpoint: zonulin in blood
zonulin (ng/ml) in capillary blood before and after 12 weeks treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start2 Oct 2019
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (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 With Diarrhea (IBS-D)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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glock Health, Science and Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Wolzt, Prof. Dr., Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138186
- Sponsor's protocol ID
- G-IBS_01
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2019
- Last updated
- 13 Nov 2020
- Results posted
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double-blind, Parallel-arm Feasibility (Pilot) Study to Evaluate Safety and Clinical Efficacy of G-PUR® Treatment in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- ClinicalTrials.gov ID
- NCT04138186
- Acronym / sponsor ID
- G-IBS_01
- Keywords
- IBS, Diarrhea, Gastrointestinal function disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Glock Health, Science and Research GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Oct 2019 (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.
A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.0g G-PUR® capsules | Experimental | Device: 2.0g G-PUR®, oral administration |
| Placebo capsules | Placebo comparator | Device: Placebo, oral administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years
- Recurrent abdominal pain, at least one day/week in the last 3 months (with symptom onset at least 6 months before diagnosis), associated with two or more of the following criteria (Rome IV criteria)
- Moderate to severe abdominal pain as defined with an IBS Symptoms Severity Scale (IBS-SSS) score > 175
- Patient reports that abnormal bowel movements are usually diarrhea with more than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2. Starting during the screening/run-in phase, all patients will keep diaries of stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997)
- Stable eating habits, within one month before randomization
Key exclusion criteria (24 listed)
- Patient has exclusively constipation-predominant IBS (IBS-C) that is characterized by < 3 bowel movements/week or hard and lumpy stools (e.g. Bristol stool form types 1 or 2)
- Patient has irritable bowel syndrome with mixed bowel habits (IBS-M) with varying symptoms of constipation and diarrhea
- Calprotectin stool value > 200mg/kg stool
- Known hypersensitivity to the IMD (known aluminium and/or silicon hypersensitivity)
- Patient has failed to record >50% of daily diary entries during run-in period
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 |
|---|---|---|
| 2.0g G-PUR®, oral administrationtid for 12 weeks | Device | 2.0g G-PUR® capsules |
| Placebo, oral administrationtid for 12 weeks | Device | Placebo capsules |
Primary outcome
The rate of responders for the patient's global assessment of relief using the last four assessments in the treatment period.
Time frame: 12 weeks
24 secondary outcomes
Patient's global assessment of symptom relief measured on a 5-point Likert scale (1= very good and 5= very poor)
Time frame: 12 weeks
Incidence of adverse (and serious) events
Time frame: 12 weeks
Daily intensity of bloating using a 11-point numerical rating scale (NRS) where 0 represents no bloating discomfort and 10 represents very severe bloating discomfort
Time frame: 12 weeks
Daily urgency using a 11-point numerical rating scale (NRS) where 0 represents no defecation urgency and 10 represents worst imaginable urgency
Time frame: 12 weeks
Daily stool frequency
Time frame: 12 weeks
Patient compliance with daily diary reporting
Time frame: 12 weeks
ePRO usability using a paper questionnaire
Time frame: 12 weeks
Worst daily abdominal pain using a 11-point NRS
Time frame: 12 weeks
Daily stool consistency using the Bristol Stool Form Scale (Type 1 separate hard lumps, like nuts (hard to pass); Type 7 watery, no solid pieces, entirely liquid)
Time frame: 12 weeks
Responder rate (ie weekly and daily) of the combined endpoint: worst daily abdominal pain and daily stool consistency
Time frame: 12 weeks
Additional responder analyses (i.e. weekly and daily) of IBS symptoms listed all above evaluating different change in symptom intensity with treatment (i.e., greater than or equal to 30, 40 and 50 percent change in intensity compared with baseline)
Time frame: 12 weeks
Number of pain-free days
Time frame: 12 weeks
Assessment of gastrointestinal symptoms using the IBS-SSS during each onsite visit;
Time frame: 12 weeks
Quality of Life using validated generic SF12 questionnaire
Time frame: 12 weeks
Hospital anxiety and depression scale (HADS)
Time frame: 12 weeks
Stress response using the perceived stress questionnaire
Time frame: 12 weeks
Use of rescue medication (to be assessed daily)
Time frame: 12 weeks
Exploratory endpoint: bile acid in stool
Time frame: 12 weeks
Exploratory endpoint: zonulin in stool
Time frame: 12 weeks
Exploratory endpoint: microbiome in stool
Time frame: 12 weeks
Exploratory endpoint: HBD2 in stool
Time frame: 12 weeks
Exploratory endpoint: gluten in stool
Time frame: 12 weeks
Exploratory endpoint: IDO in blood
Time frame: 12 weeks
Exploratory endpoint: zonulin in blood
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome With Diarrhea (IBS-D)
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Recruiting
Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
Irritable Bowel Syndrome With Diarrhea
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. This study is not recruiting at the moment.
Michael Wolzt, Prof. Dr. principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.0g G-PUR®, oral administration in people with Irritable Bowel Syndrome With Diarrhea (IBS-D), run by Glock Health, Science and Research GmbH at 1 site in Austria.
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 12 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Wolzt, Prof. Dr. (+43 (0)1 40400 ext. 2981, michael.wolzt@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of responders for the patient's global assessment of relief using the last four assessments in the treatment period. (time frame: 12 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 13 Nov 2020.