UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051295 |
|---|---|
| Receipt number | R000058491 |
| Scientific Title | Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with active ulcerative colitis |
| Date of disclosure of the study information | 2023/06/11 |
| Last modified on | 2023/06/08 16:49:56 |
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Basic information
Public title
Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with active ulcerative colitis
Acronym
Follow-up study after A-FMT for active UC
Scientific Title
Follow-up study after fecal microbiota transplantation in combination with antibiotics for patients with active ulcerative colitis
Scientific Title:Acronym
Follow-up study after A-FMT for active UC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of maintenance of remission in patients who have completed A-FMT treatment (Fecal microbiota transplantation in combination with antibiotics) and post evaluation after 8 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following symptom scores will be assessed at baseline, 3, 6, 9, and 12 months
Stool frequency, stool characteristics, percentage of bloody stools, presence of mucus, nocturnal diarrhea, fecal incontinence, abdominal pain, physical condition related to enteritis (self-assessment), tenderness, fever (>38 degree celsius), diarrhea, intestinal complications (e.g. arthritis)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who participated in the preceding specific clinical study " Fecal microbiota transplantation in combination with antibiotics for patients with active ulcerative colitis".
Key exclusion criteria
Patients deemed unsuitable as subjects by the principal investigator
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Nagahara |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
nagahara@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nomura |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
ke-nomura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Metagen Therapeutics, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University Shizuoka Hospital
Kanazawa University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058491
