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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
subject will receive a low-dosage (300mg/d) of resveratrol
subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
subject will receive a low-dosage (600mg/d) of resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
Peking University
Beijing, Beijing Municipality, China
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.
Time frame: 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.
Time frame: 30 days
The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β).
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.
Time frame: 30 days
Concentration of hydrogen in Hydrogen Breath Test
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.
Time frame: 30 days
the alpha diversity and composition of gut microbiome
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.
Time frame: 30 days
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