UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 07 Month 08 Day
Date of IRB	2017 Year 09 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 06 Day
Last follow-up date	2021 Year 09 Month 01 Day
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	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032125