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

15 juin 2026 mis à jour par: Institute of Gastroenterology and Hepatology, Vietnam

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Viêt Nam
    • Hanoi
      • Hanoi, Hanoi, Viêt Nam, 10000
        • Recrutement
        • Institute of Gastroenterology and Hepatology
        • Contact:
        • Contact:
        • Chercheur principal:
          • Hang V Dao, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Ecologic Barrier First-Month Sequence
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.
Complément alimentaire: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Complément alimentaire: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
Expérimental: Ecologic Barrier Second-Month Sequence
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.
Complément alimentaire: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Complément alimentaire: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
Délai: Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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
Délai: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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)
Délai: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
Délai: Baseline (0 weeks), 4 weeks and 8 weeks
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.
Baseline (0 weeks), 4 weeks and 8 weeks
Change from baseline in gastrointestinal symptom severity score
Délai: Baseline (0 weeks), 4 weeks, and 8 weeks
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
Baseline (0 weeks), 4 weeks, and 8 weeks
Incidence rate of specific treatment-emergent adverse events (TEAEs)
Délai: 2 weeks, 4 weeks, 8 weeks and 12 weeks
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
2 weeks, 4 weeks, 8 weeks and 12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Institute of Gastroenterology and Hepatology, Vietnam

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2024

Achèvement primaire (Estimé)

30 juin 2026

Achèvement de l'étude (Estimé)

30 juin 2026

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EB2406

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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