UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039792 |
|---|---|
| Receipt number | R000045380 |
| Scientific Title | Influence of a food product containing a high amount od 1-kestose on intestinal commensals in Crohn's disease |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2023/02/20 12:46:31 |
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Basic information
Public title
Influence of a food product containing a high amount od 1-kestose on intestinal commensals in Crohn's disease
Acronym
kestose trial
Scientific Title
Influence of a food product containing a high amount od 1-kestose on intestinal commensals in Crohn's disease
Scientific Title:Acronym
kestose trial
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the effects of dayly uptake of 1-kestose on the intestinal commensals of the patients with Crohn's disease
Basic objectives2
Others
Basic objectives -Others
To make sure that 1-kestose does not worsened the symptoms of Crohn's disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the intestinal commensals of 2 and 4 months after starting daily uptake of 1-ketose compared with before and 2 months after the uptake
Key secondary outcomes
CDAI scores of 2 and 4 months after starting daily uptake of 1-ketose compared with before and 2 months after the uptake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
dayly uptake of 1-kestose containing food
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
1) 16 years old or older
2) 220 or less of CDAI score
3) no chenge of the treatment of Crohn's diease in the past 1 month and no plan of the change during the 4 months of 1-kestose uptake
Key exclusion criteria
1) antibiotics usage of 3 days or more after the registration
2) antiacids uptake such as proton pump inhibitors usage of 7 or more consectutive days
3) treatment change for Crohn's disease after the registration
4) regularly taking pre- or probiotics after the registration
5) not proper case for some medical reasons by the attended physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterlogy)
Zip code
259-1193
Address
143 Shimoyasuya, Isehara , Kanagawa, 259-1193 Japan
TEL
0463-93-1121
mmatsush@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Matsushima |
Organization
Tokai University School of Medicine
Division name
Internal Medicine (gastroenterlogy)
Zip code
259-1193
Address
143 Shimoyasuya, Isehara , Kanagawa, 259-1193 Japan
TEL
0463-93-1121
Homepage URL
mmatsush@tokai.ac.jp
Sponsor or person
Institute
Internal Medicine (gastroenterlogy)
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of clinical research, Tokai University
Address
143 Shimoyasuya, Isehara , Kanagawa, 259-1193 Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2020 | Year | 03 | Month | 12 | 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
20
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
| 2019 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045380
| 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 |
