|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03804931 |
|
Date of registration:
|
06/01/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Fecal Microbiota Transplantation for Ulcerative Colitis
|
|
Scientific title:
|
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis |
|
Date of first enrolment:
|
January 20, 2019 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03804931 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Yuqiang Nie, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Guangzhou First People's Hospital |
|
|
Name:
|
Hongli Huang, MM |
|
Address:
|
|
|
Telephone:
|
86-13631316718 |
|
Email:
|
honglisums@126.com |
|
Affiliation:
|
|
|
|
Name:
|
Hongli Huang, MM |
|
Address:
|
|
|
Telephone:
|
86-13631316718 |
|
Email:
|
honglisums@126.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Fecal Microbiota Transplantation
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Procedure: Fecal microbiota transplantation
|
|
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
|
|
Procedure: Infusion of Saline
|
|
Primary Outcome(s)
|
|
Clinical remission in patient as assessed using Mayo score
[Time Frame: 12 weeks]
|
|
Clinical improvement in patient as assessed using Mayo score
[Time Frame: 12 weeks]
|
|
Secondary Outcome(s)
|
|
Intestinal microbiota changing
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
K-2017-103-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|