About this trial
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 constipation.
Eligibility criteria
Qualifiers
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
Treatments tested in this trial
- CMTS4520 (dietary fiber probiotics)
- Placebo