The Effectiveness of Pasteurized Goat Milk in the Treatme... | NCT00333749

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

NCT00333749

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

65Actual

Phase

Phase 1

Conditions

Oral Ulcer

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jan 13, 2006

First Submission Date that Met QC Criteria

Jun 5, 2006

First Posted Date

Jun 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drinking or rinsing the mouth 2-3 times for 1 day	Biological		1
Pasturlized cow milk

Measure	Description	Time Frame
Severity of disease		3 years
Length of disease		3 years

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Miron, MD	HaEmek Medicak Center, Afula, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dan Miron		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D019226	Oral Ulcer

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004326	Drinking

Ancestor Terms

ID	Term
D004435	Eating
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided