UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000182
Receipt number 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 10:05:42

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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 or person

Institute

National cancer center

Institute

Department

Personal name



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

Value
https://center6.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