Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
15 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hang V Dao, PhD
- Número de telefone: +84 987988075
- E-mail: hangdao.fsh@gmail.com
Estude backup de contato
- Nome: Thuong T Nguyen, Bachelor
- Número de telefone: +84 983164220
- E-mail: thuongnt.huph@gmail.com
Locais de estudo
-
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Hanoi
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Hanoi, Hanoi, Vietnã, 10000
- Recrutamento
- Institute of Gastroenterology and Hepatology
-
Contato:
- Hang V Dao, PhD
- Número de telefone: +84 987988075
- E-mail: hangdao.fsh@gmail.com
-
Contato:
- Thuong T Nguyen, Bachelor
- Número de telefone: +84 983164220
- E-mail: thuongnt.huph@gmail.com
-
Investigador principal:
- Hang V Dao, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
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Experimental: 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.
|
Ecologic Barrier will be added to the standard treatment regimen during the first month of treatment.
Ecologic Barrier will be added to the standard treatment regimen during the second month of treatment.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
Prazo: 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
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Baseline (0 weeks), 2 weeks, 4 weeks, 8 weeks, and 12 weeks
|
|
Irritable Bowel Syndrome-Global Assessment of Improvement (IBS-GAI) score
Prazo: 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
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2 weeks, 4 weeks, 8 weeks, and 12 weeks
|
|
Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)
Prazo: 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.
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2 weeks, 4 weeks, 8 weeks, and 12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
Prazo: 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
Prazo: 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
|
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Incidence rate of specific treatment-emergent adverse events (TEAEs)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2024
Conclusão Primária (Estimado)
30 de junho de 2026
Conclusão do estudo (Estimado)
30 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de junho de 2026
Primeira postagem (Real)
18 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EB2406
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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