CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Constipation in Adults

February 12, 2025 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

The Efficacy and Safety of CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Constipation in Adults： a Randomized, Double-Blind, Placebo-Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

At least 100 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the CMTS4520 group (dietary fiber probiotics capsules) and the control group (placebo) after receiving washed microbiota transplantation. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Department of Microbiota Medicine & Medical Centre for Digestive Diseases,The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-

Meet all of the following inclusion criteria :

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

  2. For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and meet the following criteria:

    1. Frequency of spontaneous defecation <3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance).
    2. Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait Scale.
  3. 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:

-

All exclusion criteria below are not met:

  1. Participants with outlet obstruction constipation, such as rectal mucosal prolapse.
  2. Participants with a history of intestinal resection.
  3. 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.

  4. Participants with constipation secondary to systemic diseases affecting the digestive tract, including:

    1. Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).
    2. Muscle diseases (e.g., amyloidosis, dermatomyositis).
    3. Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15).
    4. Opioid-induced constipation.
    5. Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis).
  5. Have a history of major surgery or severe trauma within 3 months and have not fully recovered.

  6. Participants with any of the following cardiac abnormalities:

    1. New York Heart Association (NYHA) Class III or higher heart failure.
    2. Myocardial infarction or unstable angina within the past 6 months.
    3. Prolonged QTc interval on electrocardiogram (≥450ms for males, ≥470ms for females).
    4. Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias requiring pharmacological control (including grade 2 or higher atrioventricular block).
  7. Participants with poor lung function, as assessed by the investigator, that may impact study treatment, such as acute chronic obstructive pulmonary disease(COPD) or those requring long-term oral, intravenous corticosteroids (excluding inhalant/spray formulations).
  8. Uncontrolled immune diseases requring long-term systemic corticosteroid use (excluding topical use).
  9. Participants with reproductive system disorders that may cause abdominal pain (e.g., ovarian cysts, endometriosis, primary dysmenorrhea).

  10. Participants with significant laboratory abnormalities that, in the investigator's judgment, may affect safety or study completion, including:

    1. Hemoglobin <100g/L.
    2. Serum creatinine ≥1.5 times the upper limit of normal (ULN).
    3. Abnormal liver function (AST>1.5×ULN, ALT>1.5×ULN or total bilirubin >1.5×ULN).
    4. Clinically significant abnormalitieshe in routine stool tests or fecal occult blood indicating gastrointestinal lesions.
  11. Participants with active hepatitis (requiring or undergoing long-term treatment), HIV, or active tuberculosis.
  12. Participants with a history of drug or alcohol abuse (defined as consuming more than 14 standard drinks peer week: 1 standard drink= 360mL of beer, 45mL of 40% spirits, or 150mL of wine) or substance abuse.
  13. Participants with known allergies or intolerances to the investigational drug, similar drugs or excipients.
  14. Participants who have used anti-infective drugs (antibiotics, antifungals, antivirals) within 14 days prior to enrollment or require anti-infective treatment at the time of enrollment evaluation.
  15. Participants who have used drugs or foods that regulate intestinal microbiota (e.g., bifidobacterium, probiotics, prebiotics, fermented milk, yogurt) within 2 weeks prior to screening or during the study.
  16. Participants who have undergone hydrotherapy for bowel cleansing within one month prior to treatment.
  17. Women who are pregnant, breastfeeding, or unwilling to use effective contraception for 3 months after the last dose of the study drug.
  18. Participants who have participated in drug intervention clinical trials within 1 month prior to enrollment.
  19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 4 weeks after washed microbiota transplantation treatment.
Other: CMTS4520 (dietary fiber probiotics)
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 constipation.
Placebo Comparator: Control
The patient will receive placebo of equal capsules daily for 4 weeks after washed microbiota transplantation treatment.
Other: Placebo
Capsules with matching volume and consistent appearance to CMTS4520.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical response rate after treatment
Time Frame: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
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.
One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time Frame: Two-week post-CMTS4520 administration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
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.).
Two-week post-CMTS4520 administration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
The weekly usage rate of assisted defecation drugs.
Time Frame: One-week post-CMTS4520，Two-week post-CMTS4520 administration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
Percentage of days per week after CMTS4520 that assisted defecation drugs were used, which was compared to baseline.
One-week post-CMTS4520，Two-week post-CMTS4520 administration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2024CMTS4520-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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