CMTS0929 for Inflammatory Bowel Disease
CMTS0929
Digestive System Diseases+2
+ Gastroenteritis
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: February 20, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to explore a new treatment option called CMTS0929 for individuals suffering from Inflammatory Bowel Disease (IBD). The study aims to include at least 12 participants who meet specific health criteria, ensuring that they are suitable candidates for this research. IBD can significantly affect daily life, and current treatments may not work for everyone. By investigating CMTS0929, this study hopes to find an effective new therapy that could offer relief and improve quality of life for those with IBD. Participants in this study will receive the treatment and be monitored closely to gather important health data, including demographic and clinical information. After the treatment phase, there is a follow-up period where researchers assess the safety and effectiveness of CMTS0929. The study does not specify the method of administration for the treatment, but it focuses on observing the outcomes to ensure that the treatment is both safe and beneficial. No specific risks are outlined, but as with any medical study, there is careful monitoring to ensure participant safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, ChinaOpen Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University in Google Maps