UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001415
Receipt number R000001724
Scientific Title Effect of daily intake of broccoli sprouts on Helicbacter pylori-induced gastritis in humans.
Date of disclosure of the study information 2008/10/07
Last modified on 2009/12/21 21:26:36

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Basic information

Public title

Effect of daily intake of broccoli sprouts on Helicbacter pylori-induced gastritis in humans.

Acronym

BS-HP Trial

Scientific Title

Effect of daily intake of broccoli sprouts on Helicbacter pylori-induced gastritis in humans.

Scientific Title:Acronym

BS-HP Trial

Region

Japan


Condition

Condition

Helicobacter pylori-induced gastritis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine if daily intake of sulforaphane-rich broccoli sprouts ameliorates Helicobacter pylori-induced gastritis in humans

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Significant decrease in serum level of pepsinogen II

Key secondary outcomes



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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Broccoli Sprouts 70 g/day

Interventions/Control_2

Alfalfa Sprouts (Placebo control) 70 g/day

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with endoscopically diagnosed gastritis, who are infected with Helicobacter pylori

Key exclusion criteria

Persons who are taking antibiotics, or anti-ulcer drugs

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akinori Yanaka

Organization

1.Tokyo University of Science
2.University of Tsukuba

Division name

1. Clinical Pharmacology, 2. Gastroenerology

Zip code


Address

2641 Yamazaki, Noda, Chiba, 278-8510 Japan

TEL

04-7121-3675

Email



Public contact

Name of contact person

1st name
Middle name
Last name Akinori Yanaka

Organization

Tokyo University of Science

Division name

Clinical Pharmacology

Zip code


Address


TEL


Homepage URL


Email

ayanaka@rs.noda.tus.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Institute of Clinical Medicine

Institute

Department

Personal name



Funding Source

Organization

Minisitry of Education, Science and Culture

Organization

Division

Category of Funding 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

2008 Year 10 Month 07 Day


Related information

URL releasing protocol

http://cancerpreventionresearch.aacrjournals.org/cgi/content/full/2/4/353?view=long&pmid=19349290

Publication of results

Published


Result

URL related to results and publications

http://cancerpreventionresearch.aacrjournals.org/cgi/content/full/2/4/353?view=long&pmid=19349290

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

2004 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2004 Year 02 Month 01 Day

Last follow-up date

2005 Year 03 Month 01 Day

Date of closure to data entry

2005 Year 04 Month 01 Day

Date trial data considered complete

2005 Year 04 Month 01 Day

Date analysis concluded

2005 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 07 Day

Last modified on

2009 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001724


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name