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Completed

NCT Number: NCT00333749

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

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dan Miron

Afula, 18101, Israel

About this study

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. .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

Pasturlized cow milk

Biological

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

Primary outcomes

  1. Severity of disease

    Time frame: 3 years

  2. Length of disease

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 6, 2006
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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