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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMTS0929 | Biological | China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of China Microbiota Transplantation System 0929 (CMTS0929) | 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. | Four-week |
| The efficacy of China Microbiota Transplantation System 0929 (CMTS0929) | Crohn disease activity index (CDAI) for Crohn's disease (CD), the minimum value is 0, ≤ 4 is remission,5-7 is mild,8-16 is moderate, > 16 is severe, higher scores mean a worse outcome. | Four-week |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in endoscopic score | Three-month, Six-month | |
| The change in hematochezia compared with baseline | Hematochezia can be evaluated by Fecal occult blood test (FOBT) and the record of gross blood stool. The frenquence of hematochezia should be recorded. |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to enter the study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria must be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faming Zhang, PhD | Contact | 086-025-58509883 | fzhang@njmu.edu.cn | |
| Bota Cui, MD | Contact | 086-025-58509884 | cuibota@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Faming Zhang, PhD | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699894 | Background | Wortelboer K, de Jonge PA, Scheithauer TPM, Attaye I, Kemper EM, Nieuwdorp M, Herrema H. Phage-microbe dynamics after sterile faecal filtrate transplantation in individuals with metabolic syndrome: a double-blind, randomised, placebo-controlled clinical trial assessing efficacy and safety. Nat Commun. 2023 Sep 12;14(1):5600. doi: 10.1038/s41467-023-41329-z. | |
| 33217449 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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.
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| One-week, Four-week, Twelve-week, Six-month |
| The change in frequency of defecation compared with baseline | The frequency of defecation per day should be recorded. | One-week, Four-week, Twelve-week, Six-month |
| The change in abdominal pain compared with baseline | The abdominal pain should be recorded, such as 0 for none, 1 for mild, 2 for moderate, 3 for severe, 4 for very severe. | One-week, Four-week, Twelve-week, Six-month |
| The incidence of IBD-related complications | Intestinal perforation, massive gastrointestinal bleeding, megacolon, malignancies associated with colorectal cancer or small intestine cancer | One-week, Four-week, Twelve-week, Six-month |
| The rate of surgical intervention | Six-month |
| The safety of CMTS0929 | 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.) | Immediately, One-week, Two-week, Four-week, Three-month, Six-month |
| Shaukat A, Shyne M, Mandel JS, Snover D, Church TR. Colonoscopy With Polypectomy Reduces Long-Term Incidence of Colorectal Cancer in Both Men and Women: Extended Results From the Minnesota Colon Cancer Control Study. Gastroenterology. 2021 Mar;160(4):1397-1399.e3. doi: 10.1053/j.gastro.2020.11.014. Epub 2020 Nov 17. No abstract available. |
| 29691757 | Background | 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. |
| 35643170 | Background | 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. |
| 27914657 | Background | 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. |
| 28002398 | Background | Hodson R. Inflammatory bowel disease. Nature. 2016 Dec 21;540(7634):S97. doi: 10.1038/540S97a. No abstract available. |