Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Symptom Severity Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
- •18 and 60 years old
- •subjects voluntarily sign informed consent forms.
排除标准
- •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
研究组 & 干预措施
prebiotic intervention
subjects receive different levels of prebiotics
干预措施: Prebiotic_M (Dietary Supplement)
prebiotic intervention
subjects receive different levels of prebiotics
干预措施: Prebiotic_H (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
干预措施: resveratrol_L (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
干预措施: resveratrol_H (Dietary Supplement)
resveratrol intervention
participants receive different levels of resveratrol
干预措施: placebo_resveratrol (Other)
prebiotic intervention
subjects receive different levels of prebiotics
干预措施: Prebiotic_L (Dietary Supplement)
prebiotic intervention
subjects receive different levels of prebiotics
干预措施: placebo_Bif (Other)
结局指标
主要结局
Irritable Bowel Syndrome Symptom Severity Scale
时间窗: 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
时间窗: 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.
次要结局
- 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)