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

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Ecologic Barrier
  Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
• Пищевая добавка Ecologic Barrier
  Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.

Первичные конечные точки

• Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points [Срок оценки: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks]
• Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score [Срок оценки: 2 weeks, 4 weeks, 8 weeks, and 12 weeks]
• Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR) [Срок оценки: 2 weeks, 4 weeks, 8 weeks, and 12 weeks]

Вторичные конечные точки (3)

• Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores [Срок оценки: Baseline (0 weeks), 4 weeks and 8 weeks]
• Change from baseline in gastrointestinal symptom severity score [Срок оценки: Baseline (0 weeks), 4 weeks, and 8 weeks]
• Incidence rate of specific treatment-emergent adverse events (TEAEs) [Срок оценки: 2 weeks, 4 weeks, 8 weeks and 12 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Вьетнам · 1 центр

• Institute of Gastroenterology and Hepatology — Hanoi

Идентификаторы

NCT: NCT07656623 · EB2406

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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