The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

NCT03426683 | Completed DMC

• 1 other identifier: 2017004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease(IBD)

Keywords

Inflammatory Bowel Disease(IBD); Ulcerative colitis(UC); Crohn's disease(CD); intestinal microbiota transplantation; microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change of CDAI

  1 month, 3 months, 6months,12 months

• Relief of gastrointestinal symptoms

  1 months, 3 months, 6 months, 12months

• Changes of gut microbiota

  1 months, 3 months, 6 months, 12months

Study Arms (2)

Standardized IMT

EXPERIMENTAL

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

traditional drugs

NO INTERVENTION

The patients will receive traditional medicine treatment as usual.

Interventions

Intestinal Microbiota Transplantation OTHER

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.

Standardized IMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

Location

Related Publications (2)

• Chen Q, Fan Y, Zhang B, Yan C, Zhang Q, Ke Y, Chen Z, Wang L, Shi H, Hu Y, Huang Q, Su J, Xie C, Zhang X, Zhou L, Ren J, Xu H. Capsulized Fecal Microbiota Transplantation Induces Remission in Patients with Ulcerative Colitis by Gut Microbial Colonization and Metabolite Regulation. Microbiol Spectr. 2023 Jun 15;11(3):e0415222. doi: 10.1128/spectrum.04152-22. Epub 2023 Apr 24.

  PMID: 37093057 DERIVED

• Chen Q, Fan Y, Zhang B, Yan C, Chen Z, Wang L, Hu Y, Huang Q, Su J, Ren J, Xu H. Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. Front Cell Infect Microbiol. 2023 Jan 5;12:1086885. doi: 10.3389/fcimb.2022.1086885. eCollection 2022.

  PMID: 36683707 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: an open label, parallel study

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: February 8, 2018
• Study Start: November 21, 2017
• Primary Completion: October 29, 2021
• Study Completion: December 30, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

CN (1)