CMTS0929 for Inflammatory Bowel Disease

NCT ID: NCT06844708

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2030-07-01

Brief Summary

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of China Microbiota Transplantation System 0929 (CMTS0929) for patients with inflammatory bowel disease (IBD).

Detailed Description

At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics and clinical data will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.

Conditions

Inflammatory Bowel Disease (IBD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Eligible subjects will receive treatment with China Microbiota Transplantation System 0929 (CMTS0929). They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.

Group Type: EXPERIMENTAL

CMTS0929

Intervention Type: BIOLOGICAL

China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.

Interventions

CMTS0929

China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with inflammatory bowel disease (IBD) based on typical clinical symptoms, endoscopic findings, and histological criteria.

2. Aged between 18 and 75 years old, regardless of gender.

3. No history of using antibiotics, prebiotics, or probiotics within at least the past month.

4. Patients who can fully understand the content of the informed consent form for this trial and voluntarily sign the written informed consent.

5. Patients willing to undergo subsequent follow - up and comply with other requirements of the protocol.

Exclusion Criteria

1. Women who are pregnant or plan to become pregnant during the trial.

2. Patients who have any doubts about this technology or have a history of other risks.

3. Patients in the terminal stage of the disease or who may die during the study.

4. Patients with a history of antibiotic use within three months before transplantation or who have participated in other clinical trials.

5. Patients who have participated in any other microbiota - based therapies before enrollment.

6. Patients with positive antibodies for hepatitis B, tuberculosis, syphilis, or HIV, or those in the acute phase of any infectious disease.

7. Patients with cardiac function at grade III or higher, elevated transaminases more than twice the upper limit of the normal range, or renal insufficiency (glomerular filtration rate (GFR) less than 60 ml/min).

8. Patients with a fever of over 38 °C or clinically obvious active infections that may affect this trial.

9. Patients with severe anemia (hemoglobin < 60 g/L), granulocytopenia (absolute neutrophil count < 1.5×10⁹/L), or prolonged prothrombin time (PT) by more than 1.5 seconds.

10. Patients with obvious cardiovascular and cerebrovascular abnormalities (such as tachycardia or uncontrolled atrial fibrillation, acute coronary syndrome, stroke, or recurrent transient ischemic attacks (TIAs)); a history of arrhythmia (multifocal ventricular premature beats, bigeminy, trigeminy, congenital long QT syndrome), or patients with heart diseases that, in the judgment of the researcher, increase the risk of ventricular arrhythmia.

11. Situations identified by the researcher during the trial that may affect the patient's compliance and/or the completion of trial - related procedures, or clinical contraindications related to the pre - trial.

12. Patients who have undergone abdominal organ surgery within three months before treatment, patients less than 6 weeks after major organ surgery, or patients with poor wound healing after surgery.

13. Patients with gastrointestinal obstructive diseases, tumors, or hepatic or renal insufficiency.

14. Pregnant or lactating women, or women with the intention of becoming pregnant.

15. Patients suspected or confirmed to be drug users, or those with a history of immunodeficiency (such as positive HIV antibodies or currently receiving immunosuppressive therapy).

16. Patients with known major active infections, or those with major disorders in blood, renal, metabolic, gastrointestinal, or endocrine functions as judged by the researcher.

17. Other situations deemed unsuitable for enrollment by the researcher.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Faming Zhang, PhD

Role: CONTACT

fzhang@njmu.edu.cn

086-025-58509883

Bota Cui, MD

Role: CONTACT

cuibota@njmu.edu.cn

086-025-58509884

Facility Contacts

Faming Zhang, PhD

Role: primary

fzhang@njmu.edu.cn

086-025-58509883

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33217449 (View on PubMed)

Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.

Reference Type: BACKGROUND

PMID: 29691757 (View on PubMed)

Piovani D, Hassan C, Repici A, Rimassa L, Carlo-Stella C, Nikolopoulos GK, Riboli E, Bonovas S. Risk of Cancer in Inflammatory Bowel Diseases: Umbrella Review and Reanalysis of Meta-analyses. Gastroenterology. 2022 Sep;163(3):671-684. doi: 10.1053/j.gastro.2022.05.038. Epub 2022 May 26.

Reference Type: BACKGROUND

PMID: 35643170 (View on PubMed)

Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.

Reference Type: BACKGROUND

PMID: 27914657 (View on PubMed)

Hodson R. Inflammatory bowel disease. Nature. 2016 Dec 21;540(7634):S97. doi: 10.1038/540S97a. No abstract available.

Reference Type: BACKGROUND

PMID: 28002398 (View on PubMed)

Other Identifiers

2024CMTS0929-IBD

Identifier Type: -

Identifier Source: org_study_id