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

• ClinicalTrials.gov Identifier: NCT00333749
• Recruitment Status: Completed
• First Posted: June 6, 2006
• Last Update Posted: September 4, 2009
• Sponsor: HaEmek Medical Center, Israel
• Information provided by: HaEmek Medical Center, Israel

Tracking Information

• First Submitted Date: January 13, 2006
• First Posted Date: June 6, 2006
• Last Update Posted Date: September 4, 2009
• Study Start Date: January 2006
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2009)

• Severity of disease [ Time Frame: 3 years ]
• Length of disease [ Time Frame: 3 years ]

Original Primary Outcome Measures (submitted: June 5, 2006)

• Severity of disease
• Lengh of disease

• Change History: Complete list of historical versions of study NCT00333749 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
• Official Title: Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases
• 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. .
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Oral Ulcer

Intervention

• Biological: Drinking or rinsing the mouth 2-3 times for 1 day
• Biological: Pasturlized cow milk
  Drinking or rinsing the mouth 2-3 times for one day.

Study Arms

• Experimental: 1
  55 children < 5 years with acute oral ulcer disease.
  Intervention: Biological: Drinking or rinsing the mouth 2-3 times for 1 day
• Placebo Comparator: 2
  55 Children < 5 years with acute oral ulcer disease.
  Intervention: Biological: Pasturlized cow milk

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 3, 2009): 65
• Original Enrollment (submitted: June 5, 2006): 110
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00333749
• Other Study ID Numbers: 3870505
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dan Miron MD, HaEmek Medical Center, Israel
• Study Sponsor: HaEmek Medical Center, Israel
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dan Miron, MD; HaEmek Medicak Center, Afula, Israel

• PRS Account: HaEmek Medical Center, Israel
• Verification Date: September 2009