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

NCT ID: NCT00333749

Last Updated: 2009-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-12-31

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. .

Conditions

Oral Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

2

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

Group Type: PLACEBO_COMPARATOR

Pasturlized cow milk

Intervention Type: BIOLOGICAL

Drinking or rinsing the mouth 2-3 times for one day.

Interventions

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

Intervention Type: BIOLOGICAL

Pasturlized cow milk

Drinking or rinsing the mouth 2-3 times for one day.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

HaEmek Medical Center, Israel

Principal Investigators

Dan Miron, MD

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medicak Center, Afula, Israel

Locations

Dan Miron

Afula, , Israel

Countries

Israel

Other Identifiers

3870505

Identifier Type: -

Identifier Source: org_study_id