Clinical trial NCT06779214: Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome
Official title: Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome - Diarrhoea
Keywords: Diarrhea-predominate Irritable bowel syndrome
probiotics
polyphenols
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity Scale
timeFrame: 30 days
measure: IBS Quality of Life
timeFrame: 30 days
Secondary outcomes:
measure: The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).
timeFrame: 30 days
measure: Concentration of hydrogen in Hydrogen Breath Test
timeFrame: 30 days
measure: the alpha diversity and composition of gut microbiome
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References: