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

Peking University

Status: Not yet enrolling

Conditions: Irritable Bowel Syndrome - Diarrhoea

Treatments: Other: placebo_Bif; Dietary Supplement: resveratrol_H; Dietary Supplement: Prebiotic_L; Dietary Supplement: Prebiotic_H; Other: placebo_resveratrol; Dietary Supplement: Prebiotic_M; Dietary Supplement: resveratrol_L

Study type: Interventional

Funder types: Other

Identifiers

NCT06779214

Xuyajun197673-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
• 18 and 60 years old
• subjects voluntarily sign informed consent forms.

Exclusion criteria

• Having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes)
• Abdominal pain or diarrhea due to organic disease
• Patients with abdominal surgery
• Patients with serious mental illness and complications of heart, brain, liver, kidney and other systems
• Unable to communicate normally or skilled in the use of communication equipment
• Having serious mental problems or taking related drugs
• Drug or alcohol abusers
• People with special diets (such as vegetarians) or eating disorders or are receiving therapeutic dietary interventions
• Had used antibiotics, probiotics, other drugs that may affect the study
• Participants who are participating in other clinical trials
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

resveratrol intervention

Experimental group

Description:

participants receive different levels of resveratrol

Treatment:

Dietary Supplement: resveratrol_L

Other: placebo_resveratrol

Dietary Supplement: resveratrol_H

prebiotic intervention

Experimental group

Description:

subjects receive different levels of prebiotics

Treatment:

Dietary Supplement: Prebiotic_M

Dietary Supplement: Prebiotic_H

Dietary Supplement: Prebiotic_L

Other: placebo_Bif