CMTS4520 for Chronic Constipation in Adults
ConditionConstipation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
Frequency of spontaneous defecation <3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance).
Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait 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.
Disqualifiers
Participants with outlet obstruction constipation, such as rectal mucosal prolapse.
Participants with a history of intestinal resection.
Participants with intestinal stenosis caused by 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).
Trial design
Design model
Parallel
Treatments tested in this trial
CMTS4520 (dietary fiber probiotics)
Other interventionCMTS4520 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.
Placebo
Other interventionCapsules with matching volume and consistent appearance to CMTS4520.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 administrationSecondary outcomes
1
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 administration2
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 administraionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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