UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032746 |
|---|---|
| Receipt number | 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 | 2022/09/25 22:45:04 |
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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
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
sarihiro@gmail.com
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Katsushika Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037345
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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