UMIN-CTR Clinical Trial

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	No
Publication of results	Unpublished

Result
URL related to results and publications	No
Number of participants that the trial has enrolled	10
Results	The study was terminated because it was not possible to collect cases due to Covid-19 infection.
Results date posted	2022 Year 09 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients scheduled for endoscopic treatment for colonic polyp. 10 patients; man 10 cases, woman 0 case
Participant flow	The study was terminated because it was not possible to collect cases due to Covid-19 infection.
Adverse events	No
Outcome measures	Insufficient number of cases for analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
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	2022 Year 09 Month 25 Day
Date trial data considered complete	2022 Year 09 Month 25 Day
Date analysis concluded	2022 Year 09 Month 25 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 28 Day
Last modified on	2022 Year 09 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037345