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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000182
Receipt No. R000000255
Scientific Title Randomized double-blind placebo-controlled study of the efficacy of food containing bovine lactoferrin for suppression of colorectal polyps
Date of disclosure of the study information 2006/07/03
Last modified on 2006/07/03

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Basic information
Public title Randomized double-blind placebo-controlled study of the efficacy of food containing bovine lactoferrin for suppression of colorectal polyps
Acronym Placebo-controlled study of lactoferrin for colorectal polyps
Scientific Title Randomized double-blind placebo-controlled study of the efficacy of food containing bovine lactoferrin for suppression of colorectal polyps
Scientific Title:Acronym Placebo-controlled study of lactoferrin for colorectal polyps
Region
Japan

Condition
Condition colorectal polyps(adenomas)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of lactoferrin for suppression of colorectal polyps will be examined in a double blind placebo-controlled study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of colorectal adenoma diameter on colonoscopy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of six tablets containing lactoferrin(500 mg) daily for one year
Interventions/Control_2 Intake of six tablets containing lactoferrin(250 mg) daily for one year
Interventions/Control_3 Intake of six placbo tablets daily for one year
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have colorectal adenomas with a diameter of 5 mm or less.
Patients without total large bowel resection.
Patients without cancer.
Patients without allergy to either milk or dairy products.
Patients without any active infections, such as hepatitis B, hepatitis C, and HIV.
Patients who are not using NSAIDs regularly.
Patients with a white blood cell count of 3,000/ul or more, and a platelet count of 100,000/ul or more.
Key exclusion criteria Patients with a history of large bowel resection within three years before the start of the study.
Patients with inflammatory bowel disease.
Patients with familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer.
Patients using farnesyltransferase inhibitors regularly.
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Kozu
Organization National cancer center research center for cancer prevention and screening
Division name Cancer screening division
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National cancer center research center for cancer prevention and screening
Division name Cancer screening division
Zip code
Address
TEL
Homepage URL
Email tkozu@gan2.ncc.go.jp

Sponsor
Institute National cancer center
Institute
Department

Funding Source
Organization Morinaga milk industry co.,LTD.
Organization
Division
Category of Funding Organization Profit 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
2006 Year 07 Month 03 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 Completed
Date of protocol fixation
2001 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2002 Year 02 Month 01 Day
Last follow-up date
2006 Year 01 Month 01 Day
Date of closure to data entry
2006 Year 05 Month 01 Day
Date trial data considered complete
2006 Year 05 Month 01 Day
Date analysis concluded
2006 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2006 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000255

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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