UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043910 |
|---|---|
| Receipt number | R000049020 |
| Scientific Title | Association between brain atrophy and intestinal permeability in patients with multiple sclerosis |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/04/15 12:28:45 |
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Basic information
Public title
Association between brain atrophy and intestinal permeability in patients with multiple sclerosis
Acronym
Brain atrophy and intestinal permeability in MS
Scientific Title
Association between brain atrophy and intestinal permeability in patients with multiple sclerosis
Scientific Title:Acronym
Brain atrophy and intestinal permeability in MS
Region
| Japan |
Condition
Condition
multiple sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between the rate of brain atrophy and intestinal permeability in patients with MS
Basic objectives2
Others
Basic objectives -Others
association
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the rate of brain atrophy over 48 months and intestinal permeability measured at baseline.
Key secondary outcomes
Association between intestinal permeability at baseline and disease subtypes, disability, cognition, brain volume and disease modifying therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
A standard solution of lactulose (5 g) and mannitol (2 g)in 500 mL of tap water was ingested before bed. Urine was collected the following morning in a container (with 5 mL of thymol solution).
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
MS and related disorders (neuromyelitis optica spectrum disorders (NMOSD) and clinically isolated sydrome) will be included. MS is diagnosed by McDonald's criteria 2017 and NMOSD is diagnosed by Wingerchuk's criteria 2015.
Key exclusion criteria
Persons who have
1. pace makers or magnetic metals
2. claustrophobia
3. unstable general condition and vital signs
4. difficulty in informed consent
5. cancers or inflammatory bowel disease
6. diabetes mellitus
, pregnant women and persons who is not suitable for the participants according to the doctor's decision.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoichiro |
| Middle name | |
| Last name | Nishida |
Organization
Tokyo Medical and Dental University
Division name
Department of Neurology
Zip code
1648607
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035234
yktenuro@gmail.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yokote |
Organization
Nitobe Memorial Nakano General Hospital
Division name
Department of Neurology
Zip code
1648607
Address
4-59-16, Chuo, Nakano-ku, Tokyo
TEL
0333821231
Homepage URL
yktenuro@gmail.com
Sponsor or person
Institute
Department of Neurology and Neurological Science, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Japanese society for neuroimmunology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental Univeristy
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
0333821231
yktenuro@gmail.com
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
| 2021 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049020
