Probiotic Ecologic Barrier added to IBS-D treatment in adults with upper GI symptoms and anxiety, depression, or stress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares standard IBS-D treatment with and without the Ecologic Barrier probiotic. Participants have IBS-D and at least one upper GI symptom plus anxiety, depression, or stress. The probiotic is added for one of the two initial months, with follow-up to assess changes in IBS severity, upper GI symptoms, and mental health scores, alongside safety monitoring. Endoscopy-assisted eligibility and exclusion criteria help define the population. Results could show whether adding Ecologic Barrier provides additional symptom relief and what adverse events may occur.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Gastroenterology and Hepatology
  Hanoi, Hanoi, Vietnam Recruiting

Study contacts

• Study coordinator: Hang V Dao, PhD
• Email: hangdao.fsh@gmail.com
• Phone: +84 987988075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.