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.
At least 100 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the CMTS4520 group (dietary fiber probiotics capsules) and the control group (placebo) after receiving washed microbiota transplantation. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
CMTS4520 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.
Capsules with matching volume and consistent appearance to CMTS4520.
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
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.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
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.).
Time frame: Immediately post-CMTS4520 administration, One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
The abdominal discomfort after treatment
The scales include Gastrointestinal Symptom Rating Scale (GSRS) for abdominal discomfort.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
The abdominal discomfort after treatment
The scales include IBS Symptom Severity Scale (IBS-SSS) for abdominal discomfort.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
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The abdominal discomfort after treatment
The scales include IBS Global Improvement Scale (IBS-GIS) for abdominal discomfort.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
The quality of life after treatment
IBS Quality of Life Scale (IBS-QOL) to measure quality of life.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
The psychological states after treatment
Hospital Anxiety and Depression Scale (HADS) to measure psychological states.
Time frame: One-week post-CMTS4520 administration,Two-week post-CMTS4520 administration,Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration