CMTS0929 for Inflammatory Bowel Disease

Nanjing Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Inflammatory Bowel Disease (IBD)

Treatments: Biological: CMTS0929

Study type: Interventional

Funder types: Other

Identifiers

NCT06844708

2024CMTS0929-IBD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria to enter the study:

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

Subjects meeting any of the following exclusion criteria must be excluded from the study:

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Biological: CMTS0929