CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults

ConditionDiarrhea
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) assisted washed microbiota transplantation for patients with chronic diarhoea.

Eligibility criteria

Qualifiers

Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.

Defecation frequency is greater than or equal to 3 times per day or significantly exceeds the usual habit, with a disease duration of > 4 weeks, or recurrent diarrhea with an intermittent period within 2 - 4 weeks;

Loose stools: Types 5, 6, and 7 based on the Bristol Stool Form 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 a history of intestinal resection.

Participants with 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).

Muscle diseases (e.g., amyloidosis, dermatomyositis).

Trial design

Treatments tested in this trial

  • CMTS4520 (dietary fiber probiotics)
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups