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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032746
Receipt No. R000037345
Scientific Title Randomized trial of whey protein to prevent colorectal neoplasia
Date of disclosure of the study information 2018/06/01
Last modified on 2019/11/29

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Basic information
Public title Randomized trial of whey protein to prevent colorectal neoplasia
Acronym Randomized trial of whey protein to prevent colorectal neoplasia
Scientific Title Randomized trial of whey protein to prevent colorectal neoplasia
Scientific Title:Acronym Randomized trial of whey protein to prevent colorectal neoplasia
Region
Japan

Condition
Condition colorectal neoplasia
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will determine if whey protein can prevent colorectal neoplasia after endoscopic colon polyp resection by conducting a double blind randomized controlled clinical study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes After taking whey protein for 1 year, the prevention of colorectal neoplasia will be examined with colonoscopy.
Key secondary outcomes Adverse events due to taking whey protein will be assessed in blood tests after 6 months and 1 year.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Whey protein
Interventions/Control_2 Placebo
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 1.Person who agreed to participate in the trial with written form of consent
2.Nothing corresponds to excluding criteria
Key exclusion criteria 1.Person who is under 20 years old
2.Person who is taking laxative, prostaglandin analog or NSAIDs
3.Person who has allergy for dairy products
Target sample size 266

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Arihiro
Organization The Jikei University Katsushika Medical Center
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 125-8506
Address 6-41-2 Aoto, Katsushika-ku, Tokyo, 125-8506 JAPAN
TEL 03-3603-2111
Email sarihiro@gmail.com

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Arihiro
Organization The Jikei University Katsushika Medical Center
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 125-8506
Address 6-41-2 Aoto, Katsushika-ku, Tokyo, 125-8506 JAPAN
TEL 03-3603-2111
Homepage URL
Email sarihiro@gmail.com

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Katsushika Medical Center
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Katsushika Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-25-8Nishi-shimbashi, Minato-ku, Tokyo,1058461 JAPAN
Tel 03-3433-1111
Email rinri@jikei.ac.jp

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
2018 Year 06 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
2017 Year 11 Month 14 Day
Date of IRB
2017 Year 10 Month 12 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 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 28 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037345

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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