An interventional study of Intestinal Microbiota Transplantation in Inflammatory Bowel Disease(IBD), sponsored by Zhongshan Hospital Xiamen University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Zhongshan Hospital Xiamen University · Not applicable, Interventional, and Treatment
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.
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's enrollment of 35 is below the median of 70 across 783 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Zhongshan Hospital Xiamen University is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Other: Intestinal Microbiota Transplantation
The patients will receive traditional medicine treatment as usual.
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.
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.
Time frame: 1 month, 3 months, 6months, 12 months
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.
Time frame: 1 month, 3 months, 6months,12 months
Relief of gastrointestinal symptoms
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.
Time frame: 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.
Time frame: 1 months, 3 months, 6 months, 12months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Oct 2021, 47 months.
Of 286 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 51. This study's 47 months is above that.
Counting every sponsor, half of 299 studies reached it within 28 months; a quarter within 14 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Zhongshan Hospital Xiamen University