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
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
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
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
