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There are many limitations in the current treatments of Inflammatory Bowel Diseases(IBD) which includes Ulcerative Colitis（UC) and Crohn's Disease(CD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of Inflammatory Bowel Diseases. In recent years, a retrospective study showed that the overall efficiency of intestinal microbiota transplantation for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized intestinal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized intestinal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Intestinal Microbiota Transplantation for IBD treatment, and further to explore which major bacteria may effect in this project.
In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Intestinal Microbiota Transplantation for Ulcerative Colitis(UC) and Crohn's Disease(CD).Investigators have established a standardized isolation, store, and transport steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube or capsules.Participants in this study will be assigned to receive Standardized Intestinal Microbiota Transplantation three times a week or traditional medicine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized Intestinal Microbiota Transplantation at the start and end of the projects. At last, investigators will use 16S-rDNA to estimate the change of intestinal microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized IMT | Experimental | The patients will receive Standardized Intestinal Microbiota Transplantation(Standardized IMT). The IMT was given to mid-gut by nose-jejunum nutrition tube or capsules. It was given three times a week. |
|
| traditional drugs | No Intervention | The patients will receive traditional medicine treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intestinal Microbiota Transplantation | Other | the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized IMT three times or traditional medicine and would be followed up for at least 3 year. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of the modified Mayo score | Clinical remission defined as modified Mayo score≦2. Change from baseline will be assessed at different timepoint.The endpoint of follow-up is the time of clinical recurrence. | 1 month, 3 months, 6months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The change of CDAI | Clinical remission defined as CDAI(Crohn's disease activity index )≦150.Change from baseline will be assessed at different timepoint. The endpoint of follow-up is the time of clinical recurrence. | 1 month, 3 months, 6months,12 months |
| Relief of gastrointestinal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Xiamen University | Xiamen | Fujian | 361000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37093057 | Derived | Chen Q, Fan Y, Zhang B, Yan C, Zhang Q, Ke Y, Chen Z, Wang L, Shi H, Hu Y, Huang Q, Su J, Xie C, Zhang X, Zhou L, Ren J, Xu H. Capsulized Fecal Microbiota Transplantation Induces Remission in Patients with Ulcerative Colitis by Gut Microbial Colonization and Metabolite Regulation. Microbiol Spectr. 2023 Jun 15;11(3):e0415222. doi: 10.1128/spectrum.04152-22. Epub 2023 Apr 24. | |
| 36683707 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2017 | Feb 7, 2018 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2017 | Feb 7, 2018 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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an open label, parallel study
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The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".Change from baseline will be assessed at different timepoint. |
| 1 months, 3 months, 6 months, 12months |
| Changes of gut microbiota | Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and1 month, 3 months, 6months ,12 months after treatment. | 1 months, 3 months, 6 months, 12months |
| Derived |
| Chen Q, Fan Y, Zhang B, Yan C, Chen Z, Wang L, Hu Y, Huang Q, Su J, Ren J, Xu H. Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. Front Cell Infect Microbiol. 2023 Jan 5;12:1086885. doi: 10.3389/fcimb.2022.1086885. eCollection 2022. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |