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

Oral Ulcer Clinical Trial

Official title:

Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333749
• Other study ID #: 3870505
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2006
• Last updated: September 3, 2009
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Ulcer
• Ulcer

Intervention

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

• Pasturlized cow milk
Drinking or rinsing the mouth 2-3 times for one day.

Locations

Country	Name	City	State
Israel	Dan Miron	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of disease		3 years
Primary	Length of disease		3 years