RecruitingNot Applicable

Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress

Vietnam60 participantsStarted 2024-06-01

Plain-language summary

The aim of this clinical trial is to find out whether Ecologic Barrier is effective in supporting the treatment of irritable bowel syndrome (IBS) in adults. The main questions that this trial aims to answer are: * Does Ecologic Barrier help improve IBS severity when added to standard IBS treatment? * Does Ecologic Barrier help improve symptoms of anxiety, depression, and stress in patients with IBS? * Does Ecologic Barrier help improve upper gastrointestinal symptoms when added to standard IBS treatment? * What adverse events may occur when using Ecologic Barrier? The researchers will compare a group receiving standard symptom-based treatment with another group receiving standard treatment plus Ecologic Barrier. Participants will: * Receive IBS treatment for 2 months, with Ecologic Barrier added during either the first month or the second month, depending on random assignment. * Attend a follow-up visit after 1 month of treatment. * Take part in interviews about IBS severity, symptom improvement, adverse events, and symptoms of depression and anxiety at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Indication for upper endoscopy and colonoscopy; * Diagnosed with IBS-D according to Rome IV criteria; * Presence of at least one upper gastrointestinal symptom, including: retrosternal burning, reflux, epigastric pain, epigastric burning, postprandial discomfort, early satiety, abdominal bloating, belching, sour regurgitation, nausea/vomiting; * Manifestations of anxiety, depression, or stress, with at least one of the three DASS-21 subscale scores exceeding the normal threshold (depression score \>9 and/or anxiety score \>7 and/or stress score \>14). Exclusion Criteria: * Positive for Helicobacter pylori by rapid urease test during endoscopy or by 13C-urea breath test; * Currently using anxiolytic or antidepressant medication; * Currently or previously used antibiotics within the past month; * Currently or previously used symptomatic treatment, probiotics, or proton pump inhibitors (PPI) within the past two weeks; * History of gastrointestinal surgery; * Endoscopic findings of organic lesions: ulcer, acute inflammation, colonic polyp \>5 mm, or colonic polyp \<5 mm with suspected neoplasia; * Pregnant or breastfeeding women.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points

Timeframe: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score

Timeframe: 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)

Timeframe: 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Trial details

NCT IDNCT07656623

SponsorInstitute of Gastroenterology and Hepatology, Vietnam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Hang V Dao, PhD

+84 987988075 hangdao.fsh@gmail.com

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Diarrhea trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points

Timeframe: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score

Timeframe: 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)

Timeframe: 2 weeks, 4 weeks, 8 weeks, and 12 weeks