The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases

HaEmek Medical Center, Israel

Status and phase: Completed; Phase 1

Conditions: Oral Ulcer

Treatments: Biological: Drinking or rinsing the mouth 2-3 times for 1 day; Biological: Pasturlized cow milk

Study type: Interventional

Funder types: Other

Identifiers

NCT00333749

3870505

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 65 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

55 children \< 5 years with acute oral ulcer disease.

Treatment:

Biological: Drinking or rinsing the mouth 2-3 times for 1 day

2

Placebo Comparator group

Description:

55 Children \< 5 years with acute oral ulcer disease.

Treatment:

Biological: Pasturlized cow milk