The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases (IBD)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease(IBD)
• Intervention / Treatment: Other: Intestinal Microbiota Transplantation

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Zhongshan Hospital Affiliated to Xiamen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: microbiota; intestinal microbiota transplantation; Inflammatory Bowel Disease(IBD); Ulcerative colitis(UC); Crohn's disease(CD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2017004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No