|
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:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000025846 |
|
Date of registration:
|
01/02/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease
|
|
Scientific title:
|
A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease - A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease |
|
Date of first enrolment:
|
2017/02/01 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029717 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Dai Ishikawa |
|
Address:
|
2-1-1Hongo, Bunkyoku Tokyo
Japan |
|
Telephone:
|
03-3813-3111 |
|
Email:
|
dai@juntendo.ac.jp |
|
Affiliation:
|
Juntendo university school of medicine Department of gastroenterology |
|
|
Name:
|
Dai Ishikawa |
|
Address:
|
2-1-1Hongo, Bunkyoku Tokyo
Japan |
|
Telephone:
|
03-3813-3111 |
|
Email:
|
dai@juntendo.ac.jp |
|
Affiliation:
|
Juntendo university school of medicine Department of gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1. Patients who have severe drug allergy are excluded. 2. Donors who show abnormal findings to the screening tests including blood and feces.
Age minimum:
16years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
ulcerative colitis, Crohn's disease
|
|
Intervention(s)
|
|
Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks
|
|
Primary Outcome(s)
|
|
efficacy, analysis of microbiota
|
|
Source(s) of Monetary Support
|
|
Juntendo university school of medicine Department of gastroenterology Kyowa Hakko Kirin Co., Ltd Kyowa Hakko bio Co., Ltd
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|