NCT00333749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

1.9 years

First QC Date

January 13, 2006

Last Update Submit

September 3, 2009

Conditions

Oral Ulcer

Keywords

children

Outcome Measures

Primary Outcomes (2)

  • Severity of disease

    3 years

  • Length of disease

    3 years

Study Arms (2)

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

Drinking or rinsing the mouth 2-3 times for 1 dayBIOLOGICAL
1
Pasturlized cow milkBIOLOGICAL

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

2

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dan Miron

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Oral Ulcer

Interventions

Drinking

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

EatingNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Dan Miron, MD

    HaEmek Medicak Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

June 6, 2006

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

IL(1)