An interventional study of Gelsectan and Antispasmodic Agent in Diarrhea-predominant Irritable Bowel Syndrome and Irritable Bowel Syndrome of Diarrhea Type (IBS-D), sponsored by University Medical Center Ho Chi Minh City (UMC). Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by University Medical Center Ho Chi Minh City (UMC) · Not applicable, Interventional, and Treatment
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.
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of IBS-D based on the Rome IV criteria,8 including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Gelsectan
Participants receive Gelsectan as above, combined with a standard dose of an antispasmodic agent for 8 weeks.
Device: Gelsectan · Drug: Antispasmodic Agent
Participants receive only an antispasmodic agent (without Gelsectan) for a total duration of 8 weeks.
Drug: Antispasmodic Agent
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.
Also known as: Xyloglucan, XG-PPT-XOS
An oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.
Also known as: Antispasmodic drug
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.
Time frame: 1 month and 2 months
Incidence of adverse events
Number and severity of treatment-related and unrelated adverse events reported throughout the 2-month intervention period.
Time frame: 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.
Time frame: 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)
Time frame: 1 month and 2 months
Bloating severity
Measured on a 7-point Likert scale at baseline, 1 month, and 2 months.
Time frame: 1 month and 2 months
Abdominal pain intensity
Measured on a 7-point Likert scale at baseline, 1 month, and 2 months.
Time frame: 1 month and 2 months
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Parasympatholytics
University Medical Center Ho Chi Minh City (UMC)