Inflammatory Bowel Disease (IBD)
Conditions
Keywords
inflammatory bowel disease, CMTS0929, efficacy, safety
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.
Interventions
BIOLOGICALCMTS0929
China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of China Microbiota Transplantation System 0929 (CMTS0929) | Four-week | Partial Mayo scale for Ulcerative Colitis (UC), the minimum score is 0, the score ≤2 and no single sub-score was \>1 is clinical remission, 3-5 as mild activity, 6-10 as moderate activity, 11-12 as severe activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in hematochezia compared with baseline | One-week, Four-week, Twelve-week, Six-month | Hematochezia can be evaluated by Fecal occult blood test (FOBT) and the record of gross blood stool. The frenquence of hematochezia should be recorded. |
| The change in frequency of defecation compared with baseline | One-week, Four-week, Twelve-week, Six-month | The frequency of defecation per day should be recorded. |
| The change in abdominal pain compared with baseline | One-week, Four-week, Twelve-week, Six-month | The abdominal pain should be recorded, such as 0 for none, 1 for mild, 2 for moderate, 3 for severe, 4 for very severe. |
| The changes in endoscopic score | Three-month, Six-month | — |
| The rate of surgical intervention | Six-month | — |
| The safety of CMTS0929 | Immediately, One-week, Two-week, Four-week, Three-month, Six-month | The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: 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.) |
| The incidence of IBD-related complications | One-week, Four-week, Twelve-week, Six-month | Intestinal perforation, massive gastrointestinal bleeding, megacolon, malignancies associated with colorectal cancer or small intestine cancer |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Backup ContactBota Cui, MD
Outcome results
None listed