IBD: The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

Sponsor

Zhongshan Hospital Xiamen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03426683

Collaborator

(none)

Enrollment

Location

Arms

47.3

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease(IBD)	Other: Intestinal Microbiota Transplantation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

an open label, parallel studyan open label, parallel study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2017

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standardized IMT 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 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.
No Intervention: traditional drugs The patients will receive traditional medicine treatment as usual.

Arm

Intervention/Treatment

Experimental: Standardized IMT

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 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.

No Intervention: traditional drugs

The patients will receive traditional medicine treatment as usual.

Outcome Measures

Primary Outcome Measures

The change of the modified Mayo score [1 month, 3 months, 6months, 12 months]
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.

Secondary Outcome Measures

The change of CDAI [1 month, 3 months, 6months,12 months]
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.
Relief of gastrointestinal symptoms [1 months, 3 months, 6 months, 12months]
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.
Changes of gut microbiota [1 months, 3 months, 6 months, 12months]
Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and1 month, 3 months, 6months ,12 months after treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.