Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome
NCT06779214 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2025-01-16
Summary
The goal of this clinical trial is to learn if Bifidobacterium. animalis subsp.
Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are:
1. Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
2. What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D
Researchers will compare Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol relief the symptoms of patients with IBS-D.
Participants will:
1. Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
2. Visit the clinic once every 15 days for checkups and tests.
Conditions
- Irritable Bowel Syndrome - Diarrhoea
Interventions
- DIETARY_SUPPLEMENT
-
Prebiotic_L
subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
- DIETARY_SUPPLEMENT
-
resveratrol_L
subject will receive a low-dosage (300mg/d) of resveratrol
- DIETARY_SUPPLEMENT
-
Prebiotic_M
subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
- DIETARY_SUPPLEMENT
-
Prebiotic_H
subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
- DIETARY_SUPPLEMENT
-
resveratrol_H
subject will receive a low-dosage (600mg/d) of resveratrol
- OTHER
-
placebo_Bif
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
- OTHER
-
placebo_resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
Sponsors & Collaborators
-
Peking University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-28
- Primary Completion
- 2025-03-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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