NCT06779214

Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

We recruited patients with IBS-D. The subjects who met the inclusion criteria were randomly divided into placebo control group, Bifidobacterium. animalis subsp.Lactis A6 Strain group and resveratrol intervention. The intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. The main outcomes were: ① IBS Symptom Severity Scale (IBS-SSS), ② gut microbiota and their metabolites. The secondary outcomes were: ① IBS Quality of Life score (IBS-QOL), ② Bristol fecal traits score, ③hydrogen breath test; ④ Inflammatory markers. After the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal IBS, and provide scientific basis for the formulation of relevant clinical treatment paths.

Conditions

• Irritable Bowel Syndrome - Diarrhoea

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-03-31
• Completion: 2025-12-31
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: China