This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) assisted washed microbiota transplantation for patients with chronic diarhoea.
Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
Defecation frequency is greater than or equal to 3 times per day or significantly exceeds the usual habit, with a disease duration of > 4 weeks, or recurrent diarrhea with an intermittent period within 2 - 4 weeks;
Loose stools: Types 5, 6, and 7 based on the Bristol Stool Form Scale.
The subject or his/her legal representative has given informed consent, is fully aware of the purpose of the study, is able to communicate well with the investigator, and is able to understand and comply with the requirements of the study.
Participants with a history of intestinal resection.
Participants with organic lesions of the digestive tract (e.g., tumor, inflammation, anal fissures, Crohn's disease, ulcerative colitis, radiation enteritis, intestinal adhesions, intestinal tuberculosis) as confirmed by colonoscopy within the past 24 months.
Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).
Muscle diseases (e.g., amyloidosis, dermatomyositis).
Parallel
CMTS4520 (dietary fiber probiotics)
DrugCMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 4 weeks of CMTS4520 daily for chronic diarrhoea.
Placebo
DrugCapsules with matching volume and consistent appearance to CMTS4520.
The clinical response rate after treatment
A clinical response was described as the change of the defecation frequency and the fecal consistency scores (assessed using the Bristol Stool Form Scale) after receiving CMTS4520 and washed microbiota transplantation on the first day (D1) and the fourth week (D28) post-treatment compared to baseline, as well as the average weekly fecal consistency scores.
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
The abdominal discomfort after treatment
The scales include Gastrointestinal Symptom Rating Scale (GSRS) for abdominal discomfort.
The abdominal discomfort after treatment
The scales include IBS Symptom Severity Scale (IBS-SSS) for abdominal discomfort.
The abdominal discomfort after treatment
The scales include IBS Global Improvement Scale (IBS-GIS) for abdominal discomfort.
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