Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00333749
First received: January 13, 2006
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Oral Ulcer
Biological: Drinking or rinsing the mouth 2-3 times for 1 day
Biological: Pasturlized cow milk
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

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

Enrollment: 65
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
55 children < 5 years with acute oral ulcer disease.
Biological: Drinking or rinsing the mouth 2-3 times for 1 day
Placebo Comparator: 2
55 Children < 5 years with acute oral ulcer disease.
Biological: Pasturlized cow milk
Drinking or rinsing the mouth 2-3 times for one day.

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. .

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333749

Locations
Israel
Dan Miron
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Dan Miron, MD HaEmek Medicak Center, Afula, Israel
  More Information

No publications provided

Responsible Party: Dan Miron MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00333749     History of Changes
Other Study ID Numbers: 3870505
Study First Received: January 13, 2006
Last Updated: September 3, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
children

Additional relevant MeSH terms:
Oral Ulcer
Ulcer
Mouth Diseases
Pathologic Processes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014