Diarrhea-predominant Irritable Bowel SyndromeGELIBSNCT07000383
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
A study testing Gelsectan and Antispasmodic Agent in people with Diarrhea-predominant Irritable Bowel Syndrome and Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
This clinical study aims to investigate the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, in adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
- What is being tested?
- Gelsectan and Antispasmodic Agent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jun 2025to 31 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of IBS-D based on the Rome IV criteria,8 including:
- Recurrent abdominal pain occurring at least one day per week in the last three months, associated with at least two of the following: related to defecation, associated with a change in stool frequency, or associated with a change in stool form. These criteria must have been present during the last three months, with symptom onset at least six months prior to diagnosis;
- More than 25% of bowel movements with stool types 6 or 7 and less than 25% with stool types 1 or 2 according to the Bristol Stool Form Scale.
- Signed informed consent for study participation
Who cannot join
- Pregnant or breastfeeding women
- Known allergy to any component of the study medication
- Diagnosed with diabetes mellitus
- Patients with severe comorbidities or psychiatric disorders that impair their ability to complete questionnaires or attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, District 5, 700000
Assoc. Professor. Thong Duy Vo, M.D. Ph.D., +84 932039888, thong.vd@umc.edu.vn
Qui Huu Nguyen, M.D., +84 975560142, qui.nh@umc.edu.vn
About this study
Official title: Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome at University Medical Center Ho Chi Minh City, Vietnam: a Randomized, Open-label Clinical Trial
This clinical study aims to investigate the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, in adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) in Vietnam. IBS-D is a common digestive disorder that causes frequent diarrhea along with abdominal pain and bloating, significantly affecting patients' daily life and wellbeing.
The main goal of the study is to determine whether Gelsectan can reduce the severity of symptoms such as diarrhea, abdominal discomfort, and bloating, and improve patients' quality of life. Participants will be randomly assigned to receive either Gelsectan alone, Gelsectan combined with an antispasmodic medication, or antispasmodic medication alone. The treatment will last for two months, with regular monitoring of symptom changes and any side effects.
Read more
The investigators hypothesize that Gelsectan treatment will lead to better symptom relief and quality of life compared to standard antispasmodic treatment. The study will also carefully observe the safety profile of Gelsectan during the treatment period.
Results from this study will provide important information about the potential benefits and risks of Gelsectan for Vietnamese patients with IBS-D and may contribute to improving treatment options for this condition in Vietnam.
Read the detailed description
Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common subtypes of IBS, accounting for approximately 30-40% of all IBS cases. In developed countries, xyloglucan-the main component of Gelsectan-has been demonstrated in various studies to be a promising therapeutic option for IBS-D. Xyloglucan forms a biofilm that protects the intestinal mucosa, reduces permeability, and helps prevent the effects of inflammatory agents and functional disturbances in the gut. Clinical studies have shown that xyloglucan not only alleviates symptoms such as diarrhea, abdominal pain, and bloating, but also restores intestinal function and significantly improves the quality of life in patients with IBS-D. IBS-D is also prevalent in Vietnam; however, there is currently no published research evaluating the use of Gelsectan for the treatment of this condition in the Vietnamese population.
This study aims to evaluate the efficacy of Gelsectan in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) by assessing improvements in diarrhea, bloating, abdominal pain, and quality of life after 1 and 2 months of treatment. Additionally, the study investigates the safety profile of the product based on the frequency and severity of adverse events recorded throughout the intervention period.
This study is an open-label, randomized controlled clinical trial conducted at the Gastroenterology Outpatient Clinic of the University Medical Center Ho Chi Minh City, from April 2025 to April 2026. The study population includes patients aged 18 years and older, diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to the Rome IV criteria.
After providing informed consent, participants will be randomly assigned to one of three intervention groups: (1) Gelsectan monotherapy, (2) Gelsectan combined with an antispasmodic agent, and (3) antispasmodic therapy alone. The intervention period lasts two months, with clinical assessments conducted at baseline, after one month, and after two months of treatment. The variables recorded include clinical remission status, number of daily diarrhea episodes, intensity of abdominal pain and bloating, and quality of life scores. Adverse events will be continuously monitored and recorded according to their severity and their relationship to the intervention.
The results of this study will provide additional clinical evidence on the efficacy and safety of Gelsectan in the treatment of IBS-D, contributing to the expansion of therapeutic options in Vietnam. The application of Gelsectan may offer practical benefits in alleviating symptoms, improving patients' quality of life, and reducing healthcare costs associated with the management and treatment of IBS-D.
- Conditions
- Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
- Being tested
- Gelsectan, Antispasmodic Agent
- Keywords
- Irritable Bowel Syndrome, Gelsectan, Diarrhea-Predominant Irritable Bowel Syndrome, IBS-D, Irritable Bowel Syndrome of Diarrhea type, Xyloglucan, GELIBS
- 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.
GelsectanDevice
Also called Xyloglucan, XG-PPT-XOS
Gelsectan is a medical device containing xyloglucan, pea protein, and tannins, administered orally. Dosage: 2 capsules BID during Month 1, followed by 1 capsule BID during Month 2.
Antispasmodic AgentDrug
Also called Antispasmodic drug
An oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.
| Study group | Role | What they receive |
|---|---|---|
| Gelsectan Monotherapy | Experimental | Participants receive Gelsectan alone, administered as 2 capsules in the morning and 2 capsules in the evening during the first month; then 1 capsule in the morning and 1 in the evening during the second month. Receives: Device: Gelsectan |
| Gelsectan + Antispasmodic | Experimental | Participants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks. Receives: Device: Gelsectan; Drug: Antispasmodic Agent |
| Antispasmodic Only | Active comparator | Participants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks. Receives: Drug: Antispasmodic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission of IBS-D symptoms
Defined as the resolution of diarrhea, measured as ≤ 2 bowel movements per day with stool consistency < 5 on the Bristol Stool Form Scale, assessed at 1 and 2 months after treatment initiation.
Measured: 1 month and 2 months
Secondary outcomes (3)
Incidence of adverse events
Number and severity of treatment-related and unrelated adverse events reported throughout the 2-month intervention period.
Measured: Continuous monitoring over 2 months
IBS Severity Scoring System (IBS-SSS)
The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) is used to evaluate changes in symptom severity from baseline to Month 1 and Month 2. The IBS-SSS includes five items assessing abdominal pain severity and frequency, bloating, dissatisfaction with bowel habits, and interference with life.
Minimum score: 0; Maximum score: 500; Interpretation: Higher scores indicate worse symptom severity. Severity categories are defined as: Mild: 75-<175; Moderate: 175-<300; Severe: ≥300. A reduction of ≥50 points from baseline is considered a clinically significant improvement.
Measured: 1 month and 2 months
IBS-related quality of life (IBS-QoL) score
The "Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Questionnaire" includes 34 items across 8 domains and generates a total score ranging from 0 to 100. Interpretation: Higher scores indicate better quality of life.Total scores are categorized as follows: Very poor (<50), Poor (50-<70), Fair (70-<90), Good (90-100)
Measured: 1 month and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start15 Jun 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies 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
- Model description
- Participants will be randomized into one of three parallel groups: (1) Gelsectan monotherapy, (2) Gelsectan combined with an antispasmodic agent, and (3) antispasmodic therapy alone. Each participant will remain in their assigned group for the full two-month duration of the study, with assessments conducted at baseline, one month, and two months.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000383
- Sponsor's protocol ID
- DHYD612025
- Acronym
- GELIBS
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome at University Medical Center Ho Chi Minh City, Vietnam: a Randomized, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT07000383
- Acronym / sponsor ID
- GELIBS / DHYD612025
- Conditions
- Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
- Keywords
- Irritable Bowel Syndrome, Gelsectan, Diarrhea-Predominant Irritable Bowel Syndrome, IBS-D, Irritable Bowel Syndrome of Diarrhea type, Xyloglucan, GELIBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 2 Jun 2025 (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.
This clinical study aims to investigate the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, in adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) in Vietnam. IBS-D is a common digestive disorder that causes frequent diarrhea along with abdominal pain and bloating, significantly affecting patients' daily life and wellbeing.
The main goal of the study is to determine whether Gelsectan can reduce the severity of symptoms such as diarrhea, abdominal discomfort, and bloating, and improve patients' quality of life. Participants will be randomly assigned to receive either Gelsectan alone, Gelsectan combined with an antispasmodic medication, or antispasmodic medication alone. The treatment will last for two months, with regular monitoring of symptom changes and any side effects.
The investigators hypothesize that Gelsectan treatment will lead to better symptom relief and quality of life compared to standard antispasmodic treatment. The study will also carefully observe the safety profile of Gelsectan during the treatment period.
Results from this study will provide important information about the potential benefits and risks of Gelsectan for Vietnamese patients with IBS-D and may contribute to improving treatment options for this condition in Vietnam.
Detailed description
Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common subtypes of IBS, accounting for approximately 30-40% of all IBS cases. In developed countries, xyloglucan-the main component of Gelsectan-has been demonstrated in various studies to be a promising therapeutic option for IBS-D. Xyloglucan forms a biofilm that protects the intestinal mucosa, reduces permeability, and helps prevent the effects of inflammatory agents and functional disturbances in the gut. Clinical studies have shown that xyloglucan not only alleviates symptoms such as diarrhea, abdominal pain, and bloating, but also restores intestinal function and significantly improves the quality of life in patients with IBS-D. IBS-D is also prevalent in Vietnam; however, there is currently no published research evaluating the use of Gelsectan for the treatment of this condition in the Vietnamese population.
This study aims to evaluate the efficacy of Gelsectan in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) by assessing improvements in diarrhea, bloating, abdominal pain, and quality of life after 1 and 2 months of treatment. Additionally, the study investigates the safety profile of the product based on the frequency and severity of adverse events recorded throughout the intervention period.
This study is an open-label, randomized controlled clinical trial conducted at the Gastroenterology Outpatient Clinic of the University Medical Center Ho Chi Minh City, from April 2025 to April 2026. The study population includes patients aged 18 years and older, diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to the Rome IV criteria.
After providing informed consent, participants will be randomly assigned to one of three intervention groups: (1) Gelsectan monotherapy, (2) Gelsectan combined with an antispasmodic agent, and (3) antispasmodic therapy alone. The intervention period lasts two months, with clinical assessments conducted at baseline, after one month, and after two months of treatment. The variables recorded include clinical remission status, number of daily diarrhea episodes, intensity of abdominal pain and bloating, and quality of life scores. Adverse events will be continuously monitored and recorded according to their severity and their relationship to the intervention.
The results of this study will provide additional clinical evidence on the efficacy and safety of Gelsectan in the treatment of IBS-D, contributing to the expansion of therapeutic options in Vietnam. The application of Gelsectan may offer practical benefits in alleviating symptoms, improving patients' quality of life, and reducing healthcare costs associated with the management and treatment of IBS-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into one of three parallel groups: (1) Gelsectan monotherapy, (2) Gelsectan combined with an antispasmodic agent, and (3) antispasmodic therapy alone. Each participant will remain in their assigned group for the full two-month duration of the study, with assessments conducted at baseline, one month, and two months.
| Arm | Type | Receives |
|---|---|---|
| Gelsectan Monotherapy | Experimental | Device: GelsectanParticipants receive Gelsectan alone, administered as 2 capsules in the morning and 2 capsules in the evening during the first month; then 1 capsule in the morning and 1 in the evening during the second month. |
| Gelsectan + Antispasmodic | Experimental | Device: Gelsectan, Drug: Antispasmodic AgentParticipants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks. |
| Antispasmodic Only | Active comparator | Drug: Antispasmodic AgentParticipants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of IBS-D based on the Rome IV criteria,8 including:
- Signed informed consent for study participation
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women
- Known allergy to any component of the study medication
- Diagnosed with diabetes mellitus
- Patients with severe comorbidities or psychiatric disorders that impair their ability to complete questionnaires or attend follow-up visits
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 |
|---|---|---|
| GelsectanAlso: Xyloglucan, XG-PPT-XOSGelsectan is a medical device containing xyloglucan, pea protein, and tannins, administered orally. Dosage: 2 capsules BID during Month 1, followed by 1 capsule BID during Month 2. | Device | Gelsectan + Antispasmodic, Gelsectan Monotherapy |
| Antispasmodic AgentAlso: Antispasmodic drugAn oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D. | Drug | Antispasmodic Only, Gelsectan + Antispasmodic |
Primary outcome
Clinical remission of IBS-D symptoms
Time frame: 1 month and 2 months
Defined as the resolution of diarrhea, measured as ≤ 2 bowel movements per day with stool consistency < 5 on the Bristol Stool Form Scale, assessed at 1 and 2 months after treatment initiation.
3 secondary outcomes
Incidence of adverse events
Time frame: Continuous monitoring over 2 months
IBS Severity Scoring System (IBS-SSS)
Time frame: 1 month and 2 months
IBS-related quality of life (IBS-QoL) score
Time frame: 1 month and 2 months
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 27 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diarrhea-predominant Irritable Bowel Syndrome
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
Not yet recruitingPhase 3
Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
Diarrhea-predominant Irritable Bowel Syndrome
RecruitingPhase 2
Efficacy of Rifaximin With NAC in IBS-D
IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant)
Not yet recruiting
Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study
IBS, Diarrhea Predominant
RecruitingPhase 3
Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome
IBS (Irritable Bowel Syndrome), IBS-D (Diarrhea-predominant)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelsectan and Antispasmodic Agent in people with Diarrhea-predominant Irritable Bowel Syndrome and Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 5 inclusion and 4 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 27 May 2026. 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 Vietnam. 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. 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 Assoc. Professor. Thong Duy Vo, M.D. Ph.D. (+84 932039888, thong.vd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission of IBS-D symptoms (time frame: 1 month and 2 months). 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 27 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.