The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy, Safety and Microbiota of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

Conditions
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Inflammatory Bowel Disease(IBD)

Intervention / Treatment
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* Other: Intestinal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Standard or conventional medicine treatment ineffective of Inflammatory Bowel Diseases(IBD) patients IBD patients with recurrent symptoms IBD patients who had drug dependence or recurrence when reduced or discontinued use Untreated IBD patients who voluntarily received Standardized Intestinal Microbiota Transplantation(IMT) Written informed consent/assent as appropriate Exclusion Criteria: IBD patients with contraindications for gastrointestinal endoscopy IBD patients with indication of surgery Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/L), moderate and severe chronic obstructive pulmonary disease, severe hypertension, cerebrovascular accident, congestive heart failure, unstable angina pectoris Other serious diseases that may interfere the recruitment or affect the survival, such as cancer or acquired immune deficiency syndrome Mentally or legally disabled person Preparing for pregnancy Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up Participating in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: an open label, parallel study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized IMT<br>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<br>* 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.<br>|
| No Intervention: traditional drugs<br>The patients will receive traditional medicine treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease(IBD), Ulcerative colitis(UC), Crohn's disease(CD), intestinal microbiota transplantation, microbiota