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A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT04521205
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Zhongshan Hospital Xiamen University

Brief Summary:
There are many limitations in the current treatments of Inflammatory bowel disease(IBD). 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 IBD. In recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (FMT) for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized fecal 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 (Ulcerative Colitis and Crohn's Disease) in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized fecal 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 Fecal Microbiota Transplantation for IBD treatment, and further to explore which major microbiota may effect in this project.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease, Ulcerative Colitis Type Drug: fecal microbiota capsule Phase 1

Detailed Description:
In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We 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 capsule. Patients in this study will be assigned to receive standardized FMT three times or not 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 FMT at the start and end of the projects. At last, we will use 16S-rDNA to estimate the change of intestinal microbiota.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Trial: Efficacy, Safety of Fecal Microbiota Transplantation for Inflammatory Bowel Disease
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Standardized FMT
The patients will receive standardized FMT. The FMT was given by capsule. It was given three times a week.
Drug: fecal microbiota capsule
a capsule full of fecal microbiota extracting from the health

Placebo Comparator: Without FMT
The patients will receive FMT with blank capsule.
Drug: fecal microbiota capsule
a capsule full of fecal microbiota extracting from the health




Primary Outcome Measures :
  1. Clinical remission: the modified Mayo score and endoscopy [ Time Frame: up to one year ]
    Clinical remission defined as modified Mayo score≦2. The endpoint of follow-up is the time of clinical recurrence.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Standard or conventional medicine treatment ineffective of IBD patients
  2. IBD patients with recurrent symptoms
  3. IBD patients who had drug dependence or recurrence when reduced or discontinued use
  4. Untreated IBD patients who voluntarily received FMT

Exclusion Criteria:

  1. IBD patients with contraindications for gastrointestinal endoscopy
  2. IBD patients combined with other serious diseases such as respiratory failure, heart failure and severe immunodeficiency
  3. IBD patients with indication of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521205


Contacts
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Contact: Yanyun Fan, Doctor 18759212670 trudy@163.com

Locations
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China
Yanyun Fan Recruiting
Xiamen, China
Contact: Yanyun Fan         
Sponsors and Collaborators
Zhongshan Hospital Xiamen University
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Responsible Party: Zhongshan Hospital Xiamen University
ClinicalTrials.gov Identifier: NCT04521205    
Other Study ID Numbers: XMZSYY-AF-SC-12-03
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases