A Phase 1 interventional study of fecal microbiota capsule in Inflammatory Bowel Disease, Ulcerative Colitis Type, sponsored by Zhongshan Hospital Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Zhongshan Hospital Xiamen University · Phase 1, Interventional, and Treatment
There are many limitations in the current treatments of Inflammatory bowel disease(IBD). 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 IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal 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 (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal 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 Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.
In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We 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 capsule. Patients in this study will be assigned to receive standardized FMT three times or not 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 FMT at the start and end of the projects. At last, we will use 16S-rDNA to estimate the change of intestinal microbiota.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Zhongshan Hospital Xiamen University is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.
Drug: fecal microbiota capsule
The patients will receive FMT with blank capsule.
Drug: fecal microbiota capsule
a capsule full of fecal microbiota extracting from the health
Clinical remission: the modified Mayo score and endoscopy
Clinical remission defined as modified Mayo score≦2 (range 0-12). The endpoint of follow-up is the time of clinical recurrence. The higher scores mean a worse outcome.
Time frame: up to one year
Plan to share: No
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Studies of the drug tested here: Fecal microbiota
Zhongshan Hospital Xiamen University