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

NCT06779214 | Not Yet Recruiting DMC

• 1 other identifier: Xuyajun197673-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
2. 2.What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D
3. 3.Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
4. 4.Visit the clinic once every 15 days for checkups and tests.

Conditions

Irritable Bowel Syndrome - Diarrhoea

Keywords

Diarrhea-predominate Irritable bowel syndrome; probiotics; polyphenols

Outcome Measures

Primary Outcomes (2)

• Irritable Bowel Syndrome Symptom Severity Scale

  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

  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 Outcomes (3)

• The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).

  30 days

• Concentration of hydrogen in Hydrogen Breath Test

  30 days

• the alpha diversity and composition of gut microbiome

  30 days

Study Arms (2)

resveratrol intervention

EXPERIMENTAL

participants receive different levels of resveratrol

Dietary Supplement: resveratrol_L; Dietary Supplement: resveratrol_H; Other: placebo_resveratrol

prebiotic intervention

EXPERIMENTAL

subjects receive different levels of prebiotics

Dietary Supplement: Prebiotic_L; Dietary Supplement: Prebiotic_M; Dietary Supplement: Prebiotic_H; Other: placebo_Bif

Interventions

Prebiotic_L DIETARY_SUPPLEMENT

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

prebiotic intervention

resveratrol_L DIETARY_SUPPLEMENT

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

resveratrol intervention

Prebiotic_M DIETARY_SUPPLEMENT

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

prebiotic intervention

Prebiotic_H DIETARY_SUPPLEMENT

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

prebiotic intervention

resveratrol_H DIETARY_SUPPLEMENT

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

resveratrol intervention

placebo_Bif OTHER

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

prebiotic intervention

placebo_resveratrol OTHER

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

resveratrol intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100083, China

Location

Central Study Contacts

Fan Zhang, postgraduate

CONTACT

(86) 13260267609; zhiyouzhangfan@126.com

Yalin Zhou, postdoctor

CONTACT

13260267609; zylyingyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: January 16, 2025
• Study Start: February 28, 2025
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)