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

Institute of Gastroenterology and Hepatology, Vietnam60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome With Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

The IBS-SSS score assesses the severity of IBS symptoms based on abdominal pain intensity, abdominal pain frequency, abdominal distension, dissatisfaction with bowel habits, and interference with daily life

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

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

The IBS-GAI is a self-administered questionnaire used to assess the overall change in IBS symptoms compared to the baseline. Patients answer a question such as "Compared to the way you felt before beginning the trial, have your IBS symptoms changed?" on a 7-point Likert scale ranging from 1 (substantially worse) to 7 (substantially improved). Higher scores indicate greater improvement

Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks

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

The IBS-AR is a single, dichotomous question asked to assess if patients obtained adequate relief of their IBS symptoms. Responses are categorical (Yes or No). The outcome is reported as the percentage of participants responding "Yes" at each evaluated time point.

Time frame: 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Secondary Outcomes

Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores

The DASS-21 is a 21-item self-report questionnaire designed to measure three related negative emotional states: depression, anxiety, and stress (7 items per subscale). Each item is scored from 0 (did not apply to me at all) to 3 (applied to me very much). For each subscale (Depression, Anxiety, and Stress), the scores of its 7 items are summed and multiplied by 2. Each individual subscale yields a final score range of 0 to 42. Higher scores in each subscale indicate greater severity of the respective symptoms.

Time frame: Baseline (0 weeks), 4 weeks and 8 weeks

Change from baseline in gastrointestinal symptom severity score

Gastrointestinal symptom severity is assessed using a 10-point Visual Analog Scale (VAS). The scale ranges from 0 to 10, where a score of 0 represents "normal" (no symptoms), 1-3 represents "mild", 4-6 represents "moderate", and 7-10 represents "severe" symptoms. The final outcome is reported as the change in the total severity score from baseline to each subsequent follow-up period. Higher scores indicate greater severity of gastrointestinal symptoms

Time frame: Baseline (0 weeks), 4 weeks, and 8 weeks

Incidence rate of specific treatment-emergent adverse events (TEAEs)

The incidence rate of specific treatment-emergent adverse events (TEAEs) is actively assessed at each follow-up. The pre-specified checklist of symptoms includes: abdominal bloating, abdominal distension, bowel habit disorders, headache, dizziness, nausea, heartburn/retrosternal burning, sleep disorders, and other unlisted events. For each reported symptom, the onset time and duration will be documented

Time frame: 2 weeks, 4 weeks, 8 weeks and 12 weeks