Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
15 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hang V Dao, PhD
- Número de teléfono: +84 987988075
- Correo electrónico: hangdao.fsh@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Thuong T Nguyen, Bachelor
- Número de teléfono: +84 983164220
- Correo electrónico: thuongnt.huph@gmail.com
Ubicaciones de estudio
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Hanoi
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Hanoi, Hanoi, Vietnam, 10000
- Reclutamiento
- Institute of Gastroenterology and Hepatology
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Contacto:
- Hang V Dao, PhD
- Número de teléfono: +84 987988075
- Correo electrónico: hangdao.fsh@gmail.com
-
Contacto:
- Thuong T Nguyen, Bachelor
- Número de teléfono: +84 983164220
- Correo electrónico: thuongnt.huph@gmail.com
-
Investigador principal:
- Hang V Dao, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score at multiple time points
Periodo de tiempo: 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
Periodo de tiempo: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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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
|
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Percentage of patients achieving Irritable Bowel Syndrome-Adequate Relief (IBS-AR)
Periodo de tiempo: 2 weeks, 4 weeks, 8 weeks, and 12 weeks
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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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) subscale scores
Periodo de tiempo: Baseline (0 weeks), 4 weeks and 8 weeks
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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
|
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Change from baseline in gastrointestinal symptom severity score
Periodo de tiempo: 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
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Baseline (0 weeks), 4 weeks, and 8 weeks
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Incidence rate of specific treatment-emergent adverse events (TEAEs)
Periodo de tiempo: 2 weeks, 4 weeks, 8 weeks and 12 weeks
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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
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2 weeks, 4 weeks, 8 weeks and 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2024
Finalización primaria (Estimado)
30 de junio de 2026
Finalización del estudio (Estimado)
30 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2026
Publicado por primera vez (Actual)
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EB2406
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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