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
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
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
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
