This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation.
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). 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 2 weeks of CMTS4520 daily for chronic constipation.
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 defined as a patient achieving complete spontaneous bowel movement (CSBM) at least 50% of the time after receiving CMTS4520. CSBM was defined as the number of spontaneous defecation with complete exhaust feeling without taking remedial purgative or manual assistance.
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: Two-week post-CMTS4520 adminiatration, Four-week post-CMTS4520 administration,Eight-week post-CMTS4520 administration
The weekly usage rate of assisted defecation drugs.
Percentage of days per week after CMTS4520 that assisted defecation drugs were used, which was compared to baseline.
Time frame: One-week post-CMTS4520 administraion,Two-week post-CMTS4520 administraion, Four-week post-CMTS4520 administraion,Eight-week post-CMTS4520 administraion
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