Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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: â‘ IBS Symptom Severity Scale (IBS-SSS), â‘¡ gut microbiota and their metabolites. The secondary outcomes were: â‘ IBS Quality of Life score (IBS-QOL), â‘¡ Bristol fecal traits score, â‘¢hydrogen breath test; â‘£ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resveratrol intervention | Experimental | participants receive different levels of resveratrol |
|
| prebiotic intervention | Experimental | subjects receive different levels of prebiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic_L | Dietary Supplement | subject will receive a low-dosage (1*10^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Zhang, postgraduate | Contact | (86) 13260267609 | zhiyouzhangfan@126.com | |
| Yalin Zhou, postdoctor | Contact | 13260267609 | zylyingyang@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University | Beijing | Beijing Municipality | 100083 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| 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. |
| 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. | 30 days |