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CompletedNCT00333749Updated Sep 4, 2009

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

A Phase 1 interventional study of Drinking or rinsing the mouth 2-3 times for 1 day and Pasturlized cow milk in Oral Ulcer, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-04.

Sponsored by HaEmek Medical Center, Israel · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
6 Months to 5 Years
Sex
All
01

Study 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.

Read the 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. .

02

Conditions studied

  • Oral Ulcer

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Keywords

  • children
03

In context

Oral Ulcer

41 studies on the registry are indexed under Oral Ulcer; 7 are open to participants now.

This study's enrollment of 65 is above the median of 49 across 36 interventional studies indexed under Oral Ulcer.

Browse Oral Ulcer studies →

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age > 6 months or \< 5 years.
  • Acute (\< 48 hours) oral ulcer disease.
  • > 5 ulcers.
  • Cooperative parents .
  • Signing inform consent.

Exclusion criteria

Exclusion Criteria:

  • All types of immunosuppression, IBD, SLE, recurrent oral ulcer, disease > 48 hours, age , 6 \< months or > 5 years.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • 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

Interventions

  • BiologicalDrinking or rinsing the mouth 2-3 times for 1 day
  • BiologicalPasturlized cow milk

    Drinking or rinsing the mouth 2-3 times for one day.

06

What researchers measure

Primary outcomes

  1. Severity of disease

    Time frame: 3 years

  2. Length of disease

    Time frame: 3 years

07

Study locations

1 site
  • Dan Miron
    Afula, 18101, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00333749
Lead sponsor
HaEmek Medical Center, Israel
First posted
Jun 6, 2006
Start date
Jan 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Sep 4, 2009

Study contacts

Dan Miron, MD
principal investigator · HaEmek Medicak Center, Afula, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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