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NCT Number: NCT06779214

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

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.

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Key information

Conditions

Irritable Bowel Syndrome - Diarrhoea

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University

Beijing, Beijing Municipality, 100083, China

Location contact

Peking University

CONTACT

[email protected]

086+01082802552

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic_L

Dietary Supplement

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

resveratrol_L

Dietary Supplement

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

Prebiotic_M

Dietary Supplement

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

Prebiotic_H

Dietary Supplement

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

resveratrol_H

Dietary Supplement

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

placebo_Bif

Other

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

placebo_resveratrol

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fan Zhang, postgraduate

CONTACT

[email protected]

(86) 13260267609

Yalin Zhou, postdoctor

CONTACT

[email protected]

13260267609

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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