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Fecal Microbiota Transplantation for Ulcerative Colitis

Primary Purpose

Ulcerative Colitis, Fecal Microbiota Transplantation

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Infusion of Saline
5-Aminosalicylic acid(5-ASA) and/or Prednisone
Sponsored by
Guangzhou First People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Active, moderate to severe severity (Mayo score more than 6)
  • Safety using history of 5-ASA
  • Able to undergo endoscopy examination

Exclusion Criteria:

  • Antibiotic using in 7 days
  • High risk of toxic megacolon
  • Colon cancer or neoplasia in pathophysiology
  • Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Sites / Locations

  • Guangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Fecal microbiota transplantation

placebo fecal microbiota transplantation

Traditional treatments

Arm Description

Fecal microbiota transplantation

Infusion of Saline

Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone

Outcomes

Primary Outcome Measures

Clinical remission in patient as assessed using Mayo score
Total Mayo score less than 2 and no signal item more than 1
Clinical improvement in patient as assessed using Mayo score
Total Mayo score decreased more than 3

Secondary Outcome Measures

Intestinal microbiota changing
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota

Full Information

First Posted
January 6, 2019
Last Updated
January 12, 2019
Sponsor
Guangzhou First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03804931
Brief Title
Fecal Microbiota Transplantation for Ulcerative Colitis
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2019 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou First People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
Detailed Description
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fecal microbiota transplantation
Arm Type
Experimental
Arm Description
Fecal microbiota transplantation
Arm Title
placebo fecal microbiota transplantation
Arm Type
Sham Comparator
Arm Description
Infusion of Saline
Arm Title
Traditional treatments
Arm Type
Other
Arm Description
Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
Intervention Type
Procedure
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
Intervention Type
Procedure
Intervention Name(s)
Infusion of Saline
Intervention Description
Infusion of Saline
Intervention Type
Drug
Intervention Name(s)
5-Aminosalicylic acid(5-ASA) and/or Prednisone
Other Intervention Name(s)
Mesalazine, Prednisone
Intervention Description
Mesalazine and/or Prednisone
Primary Outcome Measure Information:
Title
Clinical remission in patient as assessed using Mayo score
Description
Total Mayo score less than 2 and no signal item more than 1
Time Frame
12 weeks
Title
Clinical improvement in patient as assessed using Mayo score
Description
Total Mayo score decreased more than 3
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intestinal microbiota changing
Description
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active, moderate to severe severity (Mayo score more than 6) Safety using history of 5-ASA Able to undergo endoscopy examination Exclusion Criteria: Antibiotic using in 7 days High risk of toxic megacolon Colon cancer or neoplasia in pathophysiology Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huiting Chen, MM
Phone
86-13926055294
Email
gracy1977@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuqiang Nie, MD
Organizational Affiliation
Guangzhou First People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongli Huang, MM
Phone
86-13631316718
Email
honglisums@126.com
First Name & Middle Initial & Last Name & Degree
Huiting chen, MM
Phone
86-13926055294
Email
gracy1977@tom.com
First Name & Middle Initial & Last Name & Degree
Haoming Xu, MM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26363929
Citation
Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
Results Reference
background

Learn more about this trial

Fecal Microbiota Transplantation for Ulcerative Colitis

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