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Impact of Infant Formula on Resolution of Cow's Milk Allergy

NCT02719405 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-07-13

No results posted yet for this study

Summary

Primary Endpoint

-The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula.

Secondary Endpoints

* Tolerance

* The transcriptional profile of milk-specific T cells by clinical outcome.
* Growth and Weight Velocity
* Stool Consistency and Frequency
* The estimated frequency of milk-specific T cells by clinical outcome.
* The TCR diversity of milk-specific T cells by clinical outcome.
* The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.
* Safety

* The rate of reported adverse events by treatment group.

Conditions

  • Milk Allergy

Interventions

DIETARY_SUPPLEMENT

Lactobacillus GG

Lactobacillus GG

DIETARY_SUPPLEMENT

Extensively Hydrolyzed Casein Formula

Extensively Hydrolyzed Casein Formula

DIETARY_SUPPLEMENT

Amino Acid Formula

Amino Acid Formula

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Wayne G Shreffler, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
120 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719405 on ClinicalTrials.gov