Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Irritable Bowel Syndrome Symptom Severity Scale
Study Overview
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:
- Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
- 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:
- Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
prebiotic intervention
subjects receive different levels of prebiotics
Intervention: Prebiotic_M (Dietary Supplement)
prebiotic intervention
subjects receive different levels of prebiotics
Intervention: Prebiotic_H (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
Intervention: resveratrol_L (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
Intervention: resveratrol_H (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
Intervention: placebo_resveratrol (Other)
prebiotic intervention
subjects receive different levels of prebiotics
Intervention: Prebiotic_L (Dietary Supplement)
prebiotic intervention
subjects receive different levels of prebiotics
Intervention: placebo_Bif (Other)
Outcomes
Primary Outcomes
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.
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
- 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)