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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00333749
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : September 4, 2009
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE January 13, 2006
First Posted Date  ICMJE June 6, 2006
Last Update Posted Date September 4, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
  • Severity of disease [ Time Frame: 3 years ]
  • Length of disease [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oral Ulcer
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2009)
65
Original Enrollment  ICMJE
 (submitted: June 5, 2006)
110
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00333749
Other Study ID Numbers  ICMJE 3870505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dan Miron MD, HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Miron, MD HaEmek Medicak Center, Afula, Israel
PRS Account HaEmek Medical Center, Israel
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP