UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of low-FODMAP diet, Crohn's disease exclusion diet against Crohn's disease
Acronym	Evaluation of low-FODMAP diet, Crohn's disease exclusion diet against Crohn's disease
Scientific Title	Evaluation of low-FODMAP diet, Crohn's disease exclusion diet against Crohn's disease
Scientific Title:Acronym	Evaluation of low-FODMAP diet, Crohn's disease exclusion diet against Crohn's disease
Region	Japan

Condition
Condition	crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of Crohn's disease exclusion diet and low FODMAP diet
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Crohn's disease activity
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Crohns disease exclusion diet 8 weeks
Interventions/Control_2	Low FODMAP diet 8 weeks
Interventions/Control_3	Exclusive enteral diet
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	Crohn's disease (mild-moderate activity)
Key exclusion criteria	Crohn's disease(severe activity), abdominal abscess, abdominal fistula, anal fistula, food allergy, antibiotics use
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Matsumoto
Organization	Kawasaki Medical School
Division name	Gastroenterology
Zip code	710-0192
Address	Matsushima577, Kurashiki city, Okayama
TEL	086-462-1111
Email	hmatsumoto0311@gmail.com

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Matsumoto
Organization	Kawasaki Medical School
Division name	Gastroenterology
Zip code	710-0192
Address	Matsushima577, Kurashiki city, Okayama
TEL	086-462-1111
Homepage URL
Email	hmatsumoto0311@gmail.com

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kawasaki Medical School
Address	Matsushima577, Kurashiki city, Okayama
Tel	086-462-1111
Email	hmatsumoto0311@gmail.com

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 04 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 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 02 Month 19 Day
Last modified on	2020 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043969