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NCT02719405 · ClinicalTrials.gov registry record · Phase 2
Impact of Infant Formula on Resolution of Cow's Milk Allergy
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT02719405: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02719405 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02719405, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Lactobacillus GG
- DIETARY_SUPPLEMENT Extensively Hydrolyzed Casein Formula
- DIETARY_SUPPLEMENT Amino Acid Formula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2016-02 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
Why NCT02719405 stopped before completion
NCT02719405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Lactobacillus GG is the first listed.
NCT02719405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02719405 about?
NCT02719405 is a clinical study titled "Impact of Infant Formula on Resolution of Cow's Milk Allergy". 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 Consis...
What is the current status of trial NCT02719405?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2016-02. Estimated completion is 2018-02.
What interventions are being tested in trial NCT02719405?
The interventions under investigation include: Lactobacillus GG (DIETARY_SUPPLEMENT), Extensively Hydrolyzed Casein Formula (DIETARY_SUPPLEMENT), Amino Acid Formula (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02719405?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02719405's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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