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.
met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
18 and 60 years old
subjects voluntarily sign informed consent forms.
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
Parallel
Prebiotic_L
Dietary supplementsubject will receive a low-dosage (1\*10\^5) of Bifidobacterium. animalis subsp.Lactis A6 Strain
resveratrol_L
Dietary supplementsubject will receive a low-dosage (300mg/d) of resveratrol
Prebiotic_M
Dietary supplementsubject will receive a medium-dosage (1\*10\^8) of Bifidobacterium. animalis subsp.Lactis A6 Strain
Prebiotic_H
Dietary supplementsubjects will receive a high-dosage (1\*10\^10) of Bifidobacterium. animalis subsp.Lactis A6 Strain
resveratrol_H
Dietary supplementsubject will receive a low-dosage (600mg/d) of resveratrol
placebo_Bif
Other interventionsubjects will receive placebo (one look-alike sunbstance that contains no prebiotics)
placebo_resveratrol
Other interventionsubjects will receive placebo (one look-alike sunbstance that contains no resveratrol)
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
