Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ecologic Barrier, Ecologic Barrier.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome With Diarrhea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of the Multispecies Probiotic Mixture Ecologic Barrier for Patients With Irritable Bowel Syndrome With Upper Gastrointestinal Symptoms and Having Anxiety, Depression, and Stress Symptoms
Overview
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.
Interventions
- Dietary supplement Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment. - Dietary supplement Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
Primary outcome measures
- Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points [Time frame: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks]
- Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score [Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks]
- Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR) [Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks]
Secondary outcome measures (3)
- Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores [Time frame: Baseline (0 weeks), 4 weeks and 8 weeks]
- Change from baseline in gastrointestinal symptom severity score [Time frame: Baseline (0 weeks), 4 weeks, and 8 weeks]
- Incidence rate of specific treatment-emergent adverse events (TEAEs) [Time frame: 2 weeks, 4 weeks, 8 weeks and 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Vietnam · 1 center
- Institute of Gastroenterology and Hepatology — Hanoi
Identifiers
NCT: NCT07656623 · EB2406