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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028203
Receipt No. R000032125
Scientific Title Usefulness of kestose with Inflammatory Bowel Disease
Date of disclosure of the study information 2017/07/12
Last modified on 2018/01/16

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Basic information
Public title Usefulness of kestose with Inflammatory Bowel Disease
Acronym Treatment with kestose for Inflammatory Bowel Disease
Scientific Title Usefulness of kestose with Inflammatory Bowel Disease
Scientific Title:Acronym Treatment with kestose for Inflammatory Bowel Disease
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of kestose in the patients with Inflammatory Bowel Disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of clinical condition in patients with Inflammatory Bowel Disease
Key secondary outcomes 1.Changes of short-chain fatty acid (Butyric acid,Acetic acid,Propionic acid etc.)
2.changes of endoscopic score
3.changes of concentration of carprotectin in feces
4.Changes of pathologic and metabolic marker (T.Cho, LDL-Cho, HDL-Cho, TG, FFA, ferritin,HbA1c,CRP,TP,ALB etc.)
5.Correlation of gut microbiota and therapeutic effect
6.Changes of body weight and BMI
7.Metabolome and protein analysis of metabolite in feces
8.Changes of bile acid
9.Correlation between expiratory noble gases, gut microbiota and NAFLD/NASH
10.Correlation between usefulness of kestose and disease prognosis in the patients with Inflammatory Bowel Disease

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 kestose
Interventions/Control_2 placebo
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed as Inflammatory Bowel Disease(ulcerative colitis,crohn disease)
Key exclusion criteria 1.Women with pregnancy or possible pregnancy
2.Patients with severe renal failure and heart failure
3.Patient who is considered to be inappropriate for entry into the trial by the investigator
4.Medical doctors decided the patients are inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL +81-52-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisaku yamada
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 tsurumai-cho, Showa-ku, Nagoya
TEL +81-52-744-2602
Homepage URL
Email kei-yama@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization B Food Science Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 12 Day
Last modified on
2018 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032125

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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