NCT00792090

Brief Summary

Impact of fermented milk in prevention of cow's milk allergy in new born and infants

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
Last Updated

November 17, 2008

Status Verified

November 1, 2008

Enrollment Period

4.5 years

First QC Date

November 14, 2008

Last Update Submit

November 14, 2008

Conditions

Milk Hypersensitivity

Keywords

allergycow's milksensibilisationfermented milkinfant formula

Outcome Measures

Primary Outcomes (1)

  • Sensibilisation and cow's milk allergy

    4, 12 and 24 months

Secondary Outcomes (2)

  • Sensitization or allergy to other allergens

    4, 12 and 24 months

  • Atopic diseases (atopic dermatitis, asthma)

    4, 12 and 24 months

Study Arms (2)

1

EXPERIMENTAL

Fermented milk

Other: Fermented milk

2

ACTIVE COMPARATOR

Standard milk

Other: Standard milk

Interventions

Fermented milkOTHER

Formula used for non breastfed children or in complement of breastfeeding

1
Standard milkOTHER

Formula used for non breastfed children or in complement of breastfeeding

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mother before the 5th month of pregnancy
  • mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
  • mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
  • atopic mother or father and at least another atopic member (sister or brother)
  • parents having given written informed consent
  • adhesion to eviction regimen for mother and child
  • parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)

You may not qualify if:

  • parents refusing to sign the informed consent
  • infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
  • known or suspected immunodeficiency in the family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital central

Nancy, 57000, France

Location

Hôpital Saint Vincent de Paul

Paris, 75014, France

Location

MeSH Terms

Conditions

Milk HypersensitivityHypersensitivity

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Christophe Dupont, PhD

    Hôpital Saint Vincent de Paul

    PRINCIPAL INVESTIGATOR

  • Denise-Anne Moneret-Vautrin, PhD

    Hôpital central

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

November 1, 2003

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

November 17, 2008

Record last verified: 2008-11

Locations

FR(2)