Impact of Infant Formula on Resolution of Cow's Milk Allergy
Public ClinicalTrials.gov record NCT02719405. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Randomized Controlled Trial to Evaluate the Effect of Infant Formula on the Resolution of Cow's Milk Allergy of Infancy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02719405
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
- Lactobacillus GG Dietary Supplement
- Extensively Hydrolyzed Casein Formula Dietary Supplement
- Amino Acid Formula Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- Up to 120 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2016
- Primary completion
- Jan 31, 2018
- Completion
- Jan 31, 2018
- Last update posted
- Jul 12, 2018
2016 – 2018
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Woburn Pediatric Associates | Woburn | Massachusetts | 01801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02719405, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 12, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02719405 live on ClinicalTrials.gov.