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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039792
Receipt No. 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 2020/03/12

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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
Email 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
Email mmatsush@tokai.ac.jp

Sponsor
Institute Internal Medicine (gastroenterlogy)
Tokai University School of Medicine
Institute
Department

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
Email 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
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 Open public 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
2021 Year 08 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
2020 Year 03 Month 12 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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