CMTS0929 for Inflammatory Bowel Disease
Early Phase 1 · Testing CMTS0929 · 1 site · The Second Hospital of Nanjing Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing CMTS0929 (a biologic) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD).
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- Subjects must meet all of the following inclusion criteria to enter the study:
- Patients diagnosed with inflammatory bowel disease (IBD) based on typical clinical symptoms, endoscopic findings, and histological criteria.
- Aged between 18 and 75 years old, regardless of gender.
Plus 3 more requirement(s). There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 12 participants are expected to take part.
- Start date: 2025-02-20 (planned).
- Main results expected around 2030-01-31 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- The efficacy of China Microbiota Transplantation System 0929 (CMTS0929) (Four-week)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD) |
| Lead sponsor | The Second Hospital of Nanjing Medical University |
| Enrollment | 12 (estimated) |
| Start date | 2025-02-20 |
| Primary completion (est.) | 2030-01-31 |
| First posted | 2025-02-25 |
| Last updated | 2025-02-25 |
| Official title | CMTS0929 for Inflammatory Bowel Disease: a Prospective, Open-label, Single-arm Clinical Study |
| ClinicalTrials.gov ID | NCT06844708 |
Interventions
- CMTS0929 (Biological)
China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing, Jiangsu | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.