Irritable Bowel Syndrome - Diarrhoea
Conditions
Keywords
Diarrhea-predominate Irritable bowel syndrome, probiotics, polyphenols
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic_L
subject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
DIETARY_SUPPLEMENTresveratrol_L
subject will receive a low-dosage (300mg/d) of resveratrol
DIETARY_SUPPLEMENTPrebiotic_M
subject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
DIETARY_SUPPLEMENTPrebiotic_H
subjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
DIETARY_SUPPLEMENTresveratrol_H
subject will receive a low-dosage (600mg/d) of resveratrol
OTHERplacebo_Bif
subjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
OTHERplacebo_resveratrol
subjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome Symptom Severity Scale | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The levels of serum inflammatory cytokines, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1β (IL-1β). | 30 days | 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. |
| Concentration of hydrogen in Hydrogen Breath Test | 30 days | 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. |
| the alpha diversity and composition of gut microbiome | 30 days | 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. |
Countries
China
Contacts
Primary ContactFan Zhang, postgraduate
Backup ContactYalin Zhou, postdoctor
Outcome results
None listed