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

January 12, 2025 updated by: Peking University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100083
        • Peking University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resveratrol intervention
participants receive different levels of resveratrol
Dietary supplement: resveratrol_L
subject will receive a low-dosage (300mg/d) of resveratrol
Dietary supplement: resveratrol_H
subject will receive a low-dosage (600mg/d) of resveratrol
Other: placebo_resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
Experimental: prebiotic intervention
subjects receive different levels of prebiotics
Dietary supplement: Prebiotic_L
subject will receive a low-dosage (1*10^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
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
Other: placebo_Bif
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome Symptom Severity Scale
Time Frame: 30 days
it is a scale to evaluate the severity of irritable bowel syndrome symptoms, and the scoring range is from 0 to 500 points. The higher the score, the more severe the symptoms.
30 days
IBS Quality of Life
Time Frame: 30 days
A scoring system is designed to mark changes in quality of life of patients, which includes 34 items with the score range of 34 to 170 scores. The higher the score, the poorer the quality of life.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).
Time Frame: 30 days
Using the ELISA method to detect inflammatory cytokines above mentioned in the serum of patients, higher levels of inflammatory cytokines suggest that the patient is in an inflammatory state.
30 days
Concentration of hydrogen in Hydrogen Breath Test
Time Frame: 30 days
The hydrogen breath test is used to evaluate whether there is excessive overgrowth of small intestinal bacterial in patients. For subjects, the peak value of hydrogen exceeding 20ppm (parts per million) is considered positive, indicating the presence of small intestinal bacterial overgrowth.
30 days
the alpha diversity and composition of gut microbiome
Time Frame: 30 days
16s rDNA is used to test the diversity and composition of gut microbiome of participants. The alpha diversity is adopted to evaluate the number of species within a community (richness) as well as the distribution of each species (evenness). the higher the indicator, the healthier the gut. The composition of gut microbiome is used to describe the abundance of beneficial and harmful bacteria. The higher the abundance of beneficial bacteria and the lower the abundance of harmful bacteria, the healthier the gut is.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2025

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xuyajun197673-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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