Irritable bowel syndrome with diarrhoea
Conditions
Interventions
Random donor group:Use random donor capsules for treatment, transplant once every other day, for a total of 3 transplants. The amount of bacteria transplanted each time is about 40g. The microbiota ca
Precise matching of donor groups:Using IBS patient model for screening, liquid live bacterial capsules from donors were used for treatment, and transplanted once every other day for a total of 3 trans
Sponsors
Bethune International Peace Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1.Gender is not limited, age: 18-59 years old; 2. Up to standard of the diagnostic criteria for Rome IV diarrheal irritable bowel syndrome (IBS-D); 3. Exclude diarrhea caused by other organic lesions: inflammatory bowel disease, food intolerance or food allergy, bacterial overgrowth of the small intestine, bile acid diarrhea, pancreatic exocrine deficiency, drug side effects, functional diarrhea, colon cancer, chronic parasitic infection, microscopic colitis, thyroid disease, celiac disease, etc.; Such as inflammatory bowel disease, Clostridium difficile infection, etc.; 4. IBS Severity Scoring System (IBS-SSS) score >= 175, moderate to severe symptoms; 5. No use of any antibiotics, probiotics or prebiotics within 1 month; 6. The results of laboratory examinations during the screening period indicate that the subject has sufficient organ function; 7. Voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiopulmonary and renal insufficiency or multi-organ failure; 2. Patients with acute perforation of esophageal gastroduodenum; 3. Patients with immunocompromised function or treated with immunosuppressive drugs; 4. Those who are unable to cooperate with mental illness or obvious impairment of consciousness; 5. Those who have evidence of alcohol or other substance dependence or abuse; 6.Serious infection (CTC AE> grade 2) within 4 weeks prior to the first dose of study drug; 7.Human immunodeficiency virus (HIV) positive; 8.Known history of active tuberculosis (TB). Subjects with suspected active TB should be examined for chest x-ray, sputum, and exclusion by clinical signs and symptoms; 9.Patients with untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 500 IU/mL, or active hepatitis C should be excluded. Inactive HBsAg carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only if the HCV RNA test result is negative, they are eligible to participate in the study; 10. Any situation in the opinion of the investigator that the participant should be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic relief of IBS-diarrhea at 1 month after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal microecological changes of IBS-diarrhea at 1 month after treatment;Gastrointestinal symptoms of IBS-diarrhea at 1 month after treatment;Quality life of IBS-diarrhea at 1 month after treatment;Symptoms of depression/anxiety of IBS-diarrhea at 1 month after treatment; | — |
Countries
China
Contacts
Public ContactNan Zheng; Haifeng Jin
Bethune International Peace Hospital
Outcome results
None listed