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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02719405
The ClinicalTrials.gov registry entry for NCT02719405 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lactobacillus GG is the first listed.
NCT02719405 reports 0 study locations.
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.
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