NCT01569776

Brief Summary

The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

March 30, 2012

Last Update Submit

June 24, 2013

Conditions

Food Hypersensitivity

Keywords

Cow milk allergyCMA

Outcome Measures

Primary Outcomes (1)

  • occurrence of allergic reactions

    occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)

    14 days

Secondary Outcomes (1)

  • Digestive Tolerance

    one week

Study Arms (2)

New Amino Acid formula

EXPERIMENTAL
Other: Amino Acid formula

Control formula

ACTIVE COMPARATOR

Commercially available Amino Acid infant formula

Other: Commercially available Amino Acid Formula

Interventions

Amino Acid formulaOTHER

Amino Acid baby formula

New Amino Acid formula
Commercially available Amino Acid FormulaOTHER

Hypoallergenic Baby formula

Control formula

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Born at term (\>36 weeks gestation)
  • months to ≤12 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
  • Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
  • Having obtained his/her legal representative's informed consent

You may not qualify if:

  • Any chromosomal or major congenital anomalies
  • Any major gastrointestinal disease or abnormalities other than CMA
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
  • Immunodeficiency
  • Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
  • Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
  • Unstable asthma
  • Severe uncontrolled eczema
  • Severe anaphylactic reaction to milk within the last 2 years
  • Severe anaphylactic reaction to breastmilk within the last 2 years
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • Currently participating in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pediatric Care Medical Group, Inc.

Huntington Beach, California, 92647, United States

Location

Allergy & Asthma Medical Group and Research Center, A P.C.

San Diego, California, 92123, United States

Location

Georgia Pollens Clinical Research Centers Inc.

Albany, Georgia, 31707, United States

Location

Allergy & Asthma Physicians

Hinsdale, Illinois, 60521, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

ENT & Allergy Associates

Newburgh, New York, 12550, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

Clinical Research Partners

Richmond, Virginia, 25233, United States

Location

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

MeSH Terms

Conditions

Food HypersensitivityMilk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anna Nowak-Wegrzyn, MD

    Mount Sinai Department of Pediatrics

    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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

US(9)