CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults

NCT06839599 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IIT-2024CMTS4520-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea

Keywords

washed microbiota transplantation; diarrhea; CMTS4520; randomized controlled study; dietary fiber; probiotics

Outcome Measures

Primary Outcomes (1)

• The clinical response rate after treatment

  A clinical response was described as the change of the defecation frequency and the fecal consistency scores (assessed using the Bristol Stool Form Scale) after receiving CMTS4520 and washed microbiota transplantation on the first day (D1) and the fourth week (D28) post-treatment compared to baseline, as well as the average weekly fecal consistency scores.

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

Secondary Outcomes (6)

• The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

  Immediately post-CMTS4520 administration, One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

• The abdominal discomfort after treatment

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

• The abdominal discomfort after treatment

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

• The abdominal discomfort after treatment

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

• The quality of life after treatment

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

Study Arms (2)

Treatment

EXPERIMENTAL

The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 4 weeks after washed microbiota transplantation treatment.

Drug: CMTS4520 (dietary fiber probiotics)

Control

PLACEBO COMPARATOR

The patient will receive placebo of equal capsules daily for 4 weeks after washed microbiota transplantation treatment.

Drug: Placebo

Interventions

CMTS4520 (dietary fiber probiotics) DRUG

CMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 4 weeks of CMTS4520 daily for chronic diarrhoea.

Treatment

Placebo DRUG

Capsules with matching volume and consistent appearance to CMTS4520.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Diarrhea secondary to intestinal infectious diseases, including but not limited to Clostridioides difficile infection, chronic bacillary dysentery, intestinal tuberculosis, and parasitic infection-induced diarrhea.
• Have a history of major surgery or severe trauma within 3 months and have not fully recovered.
• Participants with any of the following cardiac abnormalities:
• New York Heart Association (NYHA) Class III or higher heart failure.
• Myocardial infarction or unstable angina within the past 6 months.
• Prolonged QTc interval on electrocardiogram (≥450ms for males, ≥470ms for females).
• Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias requiring pharmacological control (including grade 2 or higher atrioventricular block).

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Bota Cui, MD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 21, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)