The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases
Condition: Inflammatory Bowel Disease(IBD)
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Intestinal Microbiota Transplantation
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: an open label, parallel study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease(IBD); Ulcerative colitis(UC); Crohn's disease(CD); intestinal microbiota transplantation; microbiota