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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Gastroenterology and Hepatology, Vietnam

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Ecologic Barrier
  • Ecologic Barrier

Treatment groups

60 Participants
are divided into 2 treatment groups