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
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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NOT_YET_RECRUITING
NA
180 participants
INTERVENTIONAL
2025-02-28
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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resveratrol intervention
participants receive different levels of resveratrol
resveratrol_L
subject will receive a low-dosage (300mg/d) of resveratrol
resveratrol_H
subject will receive a low-dosage (600mg/d) of resveratrol
placebo_resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
prebiotic intervention
subjects receive different levels of prebiotics
Prebiotic_L
subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
Prebiotic_M
subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
Prebiotic_H
subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
placebo_Bif
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
resveratrol_L
subject will receive a low-dosage (300mg/d) of resveratrol
Prebiotic_M
subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
Prebiotic_H
subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
resveratrol_H
subject will receive a low-dosage (600mg/d) of resveratrol
placebo_Bif
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
placebo_resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
Eligibility Criteria
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Inclusion Criteria
* 18 and 60 years old
* subjects voluntarily sign informed consent forms.
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Locations
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Peking University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Xuyajun197673-03
Identifier Type: -
Identifier Source: org_study_id
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