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NCT01569776 · ClinicalTrials.gov registry record · NA
Elemental Formula Hypoallergenicity
A NA study, sponsored by Société des Produits Nestlé (SPN).
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT01569776: Completed NA study, sponsored by Société des Produits Nestlé (SPN).
NCT01569776 is a NA study that has completed, run by Société des Produits Nestlé (SPN). The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01569776, a NA study, has completed, sponsored by Société des Produits Nestlé (SPN).
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study 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.
Primary Outcome
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Interventions
- OTHER Amino Acid formula
- OTHER Commercially available Amino Acid Formula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-04 |
| Phase | NA |
What the finished NCT01569776 record still lists
NCT01569776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Amino Acid formula is the first listed.
NCT01569776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01569776 about?
NCT01569776 is a clinical study titled "Elemental Formula Hypoallergenicity". 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 m...
What is the current status of trial NCT01569776?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2012-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01569776?
The interventions under investigation include: Amino Acid formula (OTHER), Commercially available Amino Acid Formula (OTHER).
Who is sponsoring clinical trial NCT01569776?
This trial is sponsored by Société des Produits Nestlé (SPN), which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01569776's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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