UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Dietary Intake of Broccoli Sprouts on Intestinal Microbiota and Defecation in Human Subjects -2nd Trial-
Acronym	Effects of Broccli Sprouts on Human Intestinal Microbiota and Defecation -2nd Trial-
Scientific Title	Effects of Dietary Intake of Broccoli Sprouts on Intestinal Microbiota and Defecation in Human Subjects -2nd Trial-
Scientific Title:Acronym	Effects of Broccli Sprouts on Human Intestinal Microbiota and Defecation -2nd Trial-
Region	Japan

Condition
Condition	chronic functional constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of dietary intake of sulforaphane-rich broccoli sprouts on balance of intestinal mcirobiota and defecation in patients with chronic functional constipation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	composition of beneficial and pathogenic intestinal micribiota in stool sampleobtained at 4 weeks after intervention
Key secondary outcomes	constipation score

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) 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 = sulforaphane 88 mg/day for 4 weeks)
Interventions/Control_2	alfalfa sprouts (20 g/day = sulforaphane 0 mg/day for 4 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	Female
Key inclusion criteria	female human subjects, who are basically healthy other than having chronic constipation, whose constipation score is greater than 2 points
Key exclusion criteria	1. Subjects who have organic diseases in gastrointestinal tracts. 2. Subjects who are regularily using drugs, which influence on defecation. 3. Subjects who are regularily taking foods, which influence on defecation
Target sample size	24

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

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

Sponsor
Institute	Ministry of Education and Scinece
Institute
Department

Funding Source
Organization	Murakami Farm, 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	YES
Study ID_1	2017-85
Org. issuing International ID_1	Hitachi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 13 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	2018 Year 02 Month 05 Day
Date of IRB	2018 Year 02 Month 05 Day
Anticipated trial start date	2018 Year 03 Month 25 Day
Last follow-up date	2019 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	2018 Year 05 Month 12 Day
Last modified on	2019 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037019