The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Phase 1
Completed
- Conditions
- Oral Ulcer
- Interventions
- Biological: Drinking or rinsing the mouth 2-3 times for 1 dayBiological: Pasturlized cow milk
- Registration Number
- NCT00333749
- Lead Sponsor
- HaEmek Medical Center, Israel
- 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. .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Drinking or rinsing the mouth 2-3 times for 1 day 55 children \< 5 years with acute oral ulcer disease. 2 Pasturlized cow milk 55 Children \< 5 years with acute oral ulcer disease.
- Primary Outcome Measures
Name Time Method Severity of disease 3 years Length of disease 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dan Miron
🇮🇱Afula, Israel