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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779214 on ClinicalTrials.gov