UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048762 |
|---|---|
| Receipt number | R000055554 |
| Scientific Title | Metagenome analysis of microbiota in patients with severe motor and intellectual disabilities and intervention of bifidobacterium |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/08/25 21:25:48 |
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Basic information
Public title
Metagenome analysis of microbiota in patients with severe motor and intellectual disabilities and intervention of bifidobacterium
Acronym
Intervention of bifidobacterium in SMIDs
Scientific Title
Metagenome analysis of microbiota in patients with severe motor and intellectual disabilities and intervention of bifidobacterium
Scientific Title:Acronym
Intervention of bifidobacterium in SMIDs
Region
| Japan |
Condition
Condition
Severe motor and intellectual disabilities
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We examined microbiota in patients with severe motor intellectual disabilities and intervention of bifidobacterium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metagenome analysis of microbiota before and after 4 weeks and 8 weeks during treatment, and after 4 weeks of cessation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
intervention period: 8 weeks
dosage: bifidobacterium BB536 2g/day
intervention: once a day
Interventions/Control_2
intervention period: 8 weeks
dosage: lactulose 10g/day
intervention: once a day
Interventions/Control_3
intervention period: 8 weeks
dosage: bifidobacterium BB536 2g/day+lactulose 10g/day
intervention: once a day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients with severe motor and intellectual disabilities
2)tube feeding
Key exclusion criteria
usage of anti-biotics
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Tanuma |
Organization
Tokyo Metropolitan Fuchu Medical Center for the Disabled
Division name
Department of Pediatrics
Zip code
183-8553
Address
2-9-2, Musashidai, Fuchu, Tokyo 183-8553
TEL
042-323-5115
Naoyuki_Tanuma@member.metro.tokyo.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Tanuma |
Organization
Tokyo Metropolitan Fuchu Medical Center for the Disabled
Division name
Department of Pediatrics
Zip code
183-8553
Address
2-9-2, Musashidai, Fuchu, Tokyo 183-8553
TEL
042-323-5115
Homepage URL
Naoyuki_Tanuma@member.metro.tokyo.jp
Sponsor or person
Institute
Tokyo Metropolitan Fuchu Medical Center for the Disabled
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Fuchu Medical Center for the Disabled
Address
2-9-2, Musashidai, Fuchu, Tokyo 183-8553
Tel
042-323-5115
Naoyuki_Tanuma@member.metro.tokyo.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
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055554
