Back to resultsThe Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Primary Purpose
Oral Ulcer
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Drinking or rinsing the mouth 2-3 times for 1 day
Pasturlized cow milk
Sponsored by
About this trial
This is an interventional treatment trial for Oral Ulcer focused on measuring children
Eligibility Criteria
Inclusion Criteria: Age > 6 months or < 5 years. Acute (< 48 hours) oral ulcer disease. > 5 ulcers. Cooperative parents . Signing inform consent. Exclusion Criteria: All types of immunosuppression, IBD, SLE, recurrent oral ulcer, disease > 48 hours, age , 6 < months or > 5 years.
Sites / Locations
- Dan Miron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
55 children < 5 years with acute oral ulcer disease.
55 Children < 5 years with acute oral ulcer disease.
Outcomes
Primary Outcome Measures
Severity of disease
Length of disease
Secondary Outcome Measures
Full Information
NCT ID
NCT00333749
First Posted
January 13, 2006
Last Updated
September 3, 2009
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00333749
Brief Title
The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Official Title
Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - signs and symptoms.
Detailed Description
A prospective randomized controlled study that will include 110 previously health 6months - 5 years children (55 in each group) with acute oral ulcer disease (< 48 hours). Children will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - sings and symptoms by questioner to parents, and physical examination by there physicians. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Ulcer
Keywords
children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
55 children < 5 years with acute oral ulcer disease.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
55 Children < 5 years with acute oral ulcer disease.
Intervention Type
Biological
Intervention Name(s)
Drinking or rinsing the mouth 2-3 times for 1 day
Intervention Type
Biological
Intervention Name(s)
Pasturlized cow milk
Intervention Description
Drinking or rinsing the mouth 2-3 times for one day.
Primary Outcome Measure Information:
Title
Severity of disease
Time Frame
3 years
Title
Length of disease
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age > 6 months or < 5 years.
Acute (< 48 hours) oral ulcer disease.
> 5 ulcers.
Cooperative parents .
Signing inform consent.
Exclusion Criteria:
All types of immunosuppression, IBD, SLE, recurrent oral ulcer, disease > 48 hours, age , 6 < months or > 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Miron, MD
Organizational Affiliation
HaEmek Medicak Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dan Miron
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
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