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.
Age ≥ 18 years
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
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
Parallel
Gelsectan
DeviceGelsectan 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 Agent
DrugAn oral antispasmodic medication, prescribed according to standard clinical practice for IBS-D.
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.
Incidence of adverse events
Number and severity of treatment-related and unrelated adverse events reported throughout the 2-month intervention period.
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.
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)
Bloating severity
Measured on a 7-point Likert scale at baseline, 1 month, and 2 months.
Abdominal pain intensity
Measured on a 7-point Likert scale at baseline, 1 month, and 2 months.
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