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

15. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Vietnam
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 10000
        • Rekruttering
        • Institute of Gastroenterology and Hepatology
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Hang V Dao, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Kosttilskud: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
Eksperimentel: 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.
Kosttilskud: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Kosttilskud: Ecologic Barrier
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Gastroenterology and Hepatology, Vietnam

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2024

Primær færdiggørelse (Anslået)

30. juni 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EB2406

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