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

NCT ID: NCT06779214

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Irritable Bowel Syndrome - Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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resveratrol intervention

participants receive different levels of resveratrol

Group Type EXPERIMENTAL

resveratrol_L

Intervention Type DIETARY_SUPPLEMENT

subject will receive a low-dosage (300mg/d) of resveratrol

resveratrol_H

Intervention Type DIETARY_SUPPLEMENT

subject will receive a low-dosage (600mg/d) of resveratrol

placebo_resveratrol

Intervention Type OTHER

subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)

prebiotic intervention

subjects receive different levels of prebiotics

Group Type EXPERIMENTAL

Prebiotic_L

Intervention Type DIETARY_SUPPLEMENT

subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain

Prebiotic_M

Intervention Type DIETARY_SUPPLEMENT

subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain

Prebiotic_H

Intervention Type DIETARY_SUPPLEMENT

subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain

placebo_Bif

Intervention Type OTHER

subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)

Interventions

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Prebiotic_L

subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain

Intervention Type DIETARY_SUPPLEMENT

resveratrol_L

subject will receive a low-dosage (300mg/d) of resveratrol

Intervention Type DIETARY_SUPPLEMENT

Prebiotic_M

subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain

Intervention Type DIETARY_SUPPLEMENT

Prebiotic_H

subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain

Intervention Type DIETARY_SUPPLEMENT

resveratrol_H

subject will receive a low-dosage (600mg/d) of resveratrol

Intervention Type DIETARY_SUPPLEMENT

placebo_Bif

subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)

Intervention Type OTHER

placebo_resveratrol

subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Fan Zhang, postgraduate

Role: CONTACT

(86) 13260267609

Yalin Zhou, postdoctor

Role: CONTACT

13260267609

Facility Contacts

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Peking University

Role: primary

086+01082802552

Other Identifiers

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Xuyajun197673-03

Identifier Type: -

Identifier Source: org_study_id

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