UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.
Acronym	BS-UC-2020
Scientific Title	Clinical trial on the effects of dietary intake of sulforaphane-rich broccoli sprouts on severity of ulcerative colitis.
Scientific Title:Acronym	BS-UC-2020
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine if dietary intake of sulforaphane-rich broccoli sprouts improve ulcerative colitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fecal calprotectin level (before and after 8 weeks treatment)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Broccoli Sprouts (20 g/day, 8 weeks)
Interventions/Control_2	Alfalfa Sprouts (20 g/day, 8 weeks)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age higher than 20 years. 2. Mild UC (Rachmilewits index less than 5) 3. Presence of maintenance therapy with mesalazine 4. Appropriate informed consent 5. Fecal Protectin level higher than upper limit of normal value
Key exclusion criteria	1. Regular use of lactobacillus, steroids, immuno-modulators, biological drugs, caclineurin inhibitors, JAK kinase inhibitors. 2. Fecal Protectin level less than upper limit of normal value 3. Hospitalized Patients 4. Start of ASA treatment, or iIncrease in 5-ASA within 4 weeks 5. G-CAP or L-CAP treatment within 3 months 6. Treatment with herbal medicine including quingdao 7. Any other reasons judged by the principle investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akinori Middle name Last name Yanaka
Organization	University of Tsukuba Hospital
Division name	Hitachi Medical Education and Reserach Center
Zip code	317-0077
Address	2-1-1 Jounann-cho, Hitachi-shi, Ibaraki-ken
TEL	0294-23-1111
Email	ynk-aki@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Yanaka
Organization	University of Tsukuba
Division name	Hitachi Medical Education and Research Center
Zip code	317-0077
Address	2-1-1, Jounan-cho, Hitachi-shi, Ibaraki-ken
TEL	0294-23-1111
Homepage URL
Email	ynk-aki@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hitachi General Hospital
Address	2-1-1, Jounan-cho, Hitachi-shi, Ibaraki-ken
Tel	0294-23-1111
Email	masahiro.miura.cz@hitachi.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 10 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	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 03 Day
Date of IRB	2020 Year 08 Month 31 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 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 10 Month 01 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047736

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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