Constipation
Conditions
Keywords
CMTS4520, constipation, randomized controlled trial, dietary fiber, probiotics
Brief summary
This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation.
Detailed description
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.
Interventions
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.
OTHERPlacebo
Capsules with matching volume and consistent appearance to CMTS4520.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
\- Meet all of the following inclusion criteria : 1. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female. 2. For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and meet the following criteria: 1. Frequency of spontaneous defecation \<3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance). 2. Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait Scale. 3. 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.
Exclusion criteria
\- All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical response rate after treatment | One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 | Two-week post-CMTS4520 adminiatration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration | 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 weekly usage rate of assisted defecation drugs. | One-week post-CMTS4520 administraion，Two-week post-CMTS4520 administraion, Four-week post-CMTS4520 administraion，Eight-week post-CMTS4520 administraion | Percentage of days per week after CMTS4520 that assisted defecation drugs were used, which was compared to baseline. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui
Outcome results
None listed