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

NCT07656623 | Recruiting

• 1 other identifier: EB2406
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

Irritable bowel syndrome; IBS-D; Probiotics; DASS-21; Upper gastrointestinal symptoms; Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  2 weeks, 4 weeks, 8 weeks, and 12 weeks

Secondary Outcomes (3)

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

  Baseline (0 weeks), 4 weeks and 8 weeks

• Change from baseline in gastrointestinal symptom severity score

  Baseline (0 weeks), 4 weeks, and 8 weeks

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

  2 weeks, 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Ecologic Barrier First-Month Sequence

EXPERIMENTAL

This group included IBS-D patients who were prescribed a standard 2-month treatment regimen and received the study product as an add-on therapy during the first month.

Dietary Supplement: Ecologic Barrier

Ecologic Barrier Second-Month Sequence

EXPERIMENTAL

This group included IBS-D patients who were prescribed a standard 2-month treatment regimen and received the study product as an add-on therapy during the second month.

Dietary Supplement: Ecologic Barrier

Interventions

Ecologic Barrier DIETARY_SUPPLEMENT

Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.

Ecologic Barrier First-Month Sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Gastroenterology and Hepatology, Vietnam: lead

Study Sites (1)

Institute of Gastroenterology and Hepatology

Hanoi, Hanoi, 10000, Vietnam

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Hang V Dao, PhD

CONTACT

+84 987988075; hangdao.fsh@gmail.com

Thuong T Nguyen, Bachelor

CONTACT

+84 983164220; thuongnt.huph@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2024
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

VN (1)