UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053079 |
|---|---|
| Receipt number | R000060524 |
| Scientific Title | Epidemiological study of intestinal permeability in patients with neurological diseases |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/12/12 20:26:14 |
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Basic information
Public title
Epidemiological study of intestinal permeability in patients with neurological diseases
Acronym
Epidemiological study of intestinal permeability in patients with neurological diseases
Scientific Title
Epidemiological study of intestinal permeability in patients with neurological diseases
Scientific Title:Acronym
Epidemiological study of intestinal permeability in patients with neurological diseases
Region
| Japan |
Condition
Condition
neurological diseases
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify intestinal permeability in each of neurological disease
Basic objectives2
Others
Basic objectives -Others
Identification of the frequency and severity of intestinal permeability in each of neurological diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the frequency of intestinal permeability and its association with severity and prognosis in each of neurological disease
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
After fasting for at least 12 hours, drink 10 g of lactulose and 2 g of mannitol dissolved in 250 mL of water, and collect a portion of the urine after storing it for 6 hours.
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
1. patients with neurological disorders who are 20 years of age or older at the time consent is obtained
2. patients who have given written consent to participate in this study
Key exclusion criteria
1. patients with galactosemia
2. patients with severe intolerance to sugar alcohols or allergy to foods containing sugar alcohols
3. patients who are taking alpha-glucosidase
4. patients who are deemed unsuitable by the physician in charge
5. patients whose consent could not be obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Syuuichirou |
| Middle name | |
| Last name | Suzuki |
Organization
Sapporo Medical University
Division name
Division of Neurology
Zip code
0608543
Address
South-1, West-16, Chuo-ku, Sapporo
TEL
0116112111(38210)
ssuzu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Syuuichirou |
| Middle name | |
| Last name | Suzuki |
Organization
Division of Neurology
Division name
Division of Neurology
Zip code
0608543
Address
South-1, West-16, Chuo-ku, Sapporo
TEL
0116112111(38210)
Homepage URL
ssuzu@sapmed.ac.jp
Sponsor or person
Institute
Department of Neurology, Sapporo Medical University
Institute
Department
Personal name
Syuuichirou Suzuki
Funding Source
Organization
Division of Neurology, Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Sapporo Medical University Hospital
Address
South-1, West-17, Chuo-ku, Sapporo
Tel
0116112111
ji-rskk@sapmed.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 | 12 | Month | 18 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
