NCT01584245

Brief Summary

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

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

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

April 23, 2012

Last Update Submit

September 15, 2014

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    12 weeks

Secondary Outcomes (1)

  • Allergic manifestations

    12 weeks

Interventions

Amino Acid formulaOTHER

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Weight loss within the past 4 weeks
  • Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
  • Birth weight greater than or equal to 1500 grams
  • Solely enteral fed
  • Infants with at least one persistent allergy symptom
  • No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
  • Signed informed consent

You may not qualify if:

  • History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
  • Metabolic disease requiring special attention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre médical

Boulogne-Billancourt, France

Location

Hôpital Saint Vincent de Paul

Lille, France

Location

Hôpital Armand Trousseau

Paris, France

Location

Hôpital Necker Enfants Malades

Paris, France

Location

Médecine Infantile 1

Vandoeuvre Lés Nancy, France

Location

Related Publications (1)

  • Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533. doi: 10.1097/MPG.0000000000001374.

    PMID: 27526059DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Delphine de Boissieu, M.D.

    Centre médical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 24, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

FR(5)