Oral Ulcer
Conditions
Keywords
children
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. .
Interventions
BIOLOGICALDrinking or rinsing the mouth 2-3 times for 1 day
BIOLOGICALPasturlized cow milk
Drinking or rinsing the mouth 2-3 times for one day.
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of disease | 3 years |
| Length of disease | 3 years |
Countries
Israel
Outcome results
None listed