UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056366 |
|---|---|
| Receipt number | R000064397 |
| Scientific Title | Patient and Donor Intestinal Microbiota-Mucosal Immune Responses in Fecal Microbiota Transplantation with Alginate for Ulcerative Colitis |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2024/12/05 10:28:30 |
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Basic information
Public title
Patient and Donor Intestinal Microbiota-Mucosal Immune Responses in Fecal Microbiota Transplantation with Alginate for Ulcerative Colitis
Acronym
Additional Considerations in Alginate Combined with Fecal Microbiota Transplantation for UC
Scientific Title
Patient and Donor Intestinal Microbiota-Mucosal Immune Responses in Fecal Microbiota Transplantation with Alginate for Ulcerative Colitis
Scientific Title:Acronym
Additional Considerations in Alginate Combined with Fecal Microbiota Transplantation for UC
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Using the samples and information obtained from the preceding conventional intervention study, Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis, the alginate add-on effect of antimicrobial combination stool transplant therapy for ulcerative colitis and its factors (gut bacteria and its effect on the organism) will be examined and evaluated in a backward and exploratory To examine and evaluate the efficacy of alginate top-up effect on ulcerative colitis. By clarifying the factors of efficacy, we will create new therapeutic agents and therapies that control the intestinal microbiota and biological responses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using the gut bacterial community structure of each patient and their donor who achieved a therapeutic response, we will explore the effects of alginate add-on and its factors.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
(1) Those who refused to participate in this study by opting out
(2) Those deemed inappropriate as research subjects by the principal investigation
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
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
dai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Ishikawa |
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
dai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University
RIKEN
Name of secondary funder(s)
Kitasato University
RIKEN
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
| 2024 | Year | 12 | Month | 06 | 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
72
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064397
