Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
Recruiting · NCT07656623 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Gastroenterology and Hepatology, Vietnam
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
2 locations listed.
- Institute of Gastroenterology and Hepatology - Hanoi, Hanoi, Vietnam
- Institute of Gastroenterology and Hepatology - Hanoi, Hanoi, Vietnam