Active — Not RecruitingPhase 1/2

CMTS4520 for Chronic Diarrhoea in Adults

China100 participantsStarted 2025-02-20

Plain-language summary

This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic diarrhoea.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
✓. Using the Rome IV criteria as the diagnostic criteria:
✓. 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.

Exclusion criteria

✕. 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.
✕. Participants with diarrhoea secondary to systemic diseases affecting the digestive tract, including:
✕. Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).
✕. Muscle diseases (e.g., amyloidosis, dermatomyositis).
✕. Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15).
✕. Opioid-induced diarrhoea.
✕. Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis).

What they're measuring

The clinical response rate after treatment

Timeframe: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

Trial details

NCT IDNCT06839586

SponsorThe Second Hospital of Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01-31

View on ClinicalTrials.gov More Diarrhoea trials