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NCT03236207 · ClinicalTrials.gov registry record · NA
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
A NA study of Cow Milk Allergy, sponsored by Société des Produits Nestlé (SPN).
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
- 12
- Study locations
NCT03236207: Completed NA study of Cow Milk Allergy, sponsored by Société des Produits Nestlé (SPN).
NCT03236207 is a NA study of Cow Milk Allergy that has completed, run by Société des Produits Nestlé (SPN). The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03236207, a NA study of Cow Milk Allergy, has completed, sponsored by Société des Produits Nestlé (SPN).
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
- 12
- Study locations
Study Summary
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.
Primary Outcome
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
Conditions Studied
Interventions
- OTHER Test extensively hydrolyzed formula
- OTHER Control extensively hydrolyzed formula
Study Locations (12)
California
- Hoag Medical Group - Huntington Beach
- Stanford University - Mountain View
New York
- Northwell Health System - Great Neck
- Icahn School of Medicine at Mount Sinai - New York
Texas
- Houston Clinical Research Associates - Houston
- Allergy Asthma Research Institute - Waco
Minnesota
- Clinical Research Institute - Plymouth
Missouri
- Midwest Clinical Research - St Louis
New Mexico
- Breathe America - Albuquerque
Oklahoma
- Allergy, Asthma and Clinical Research Center - Oklahoma City
South Carolina
- Carolina ENT - Orangeburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2018-11-06 |
| Phase | NA |
What the finished NCT03236207 record still lists
NCT03236207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Cow Milk Allergy appearing as the primary indexed condition, and to 2 interventions - of which Test extensively hydrolyzed formula is the first listed.
NCT03236207 lists 12 locations in 9 states (California, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT03236207 about?
NCT03236207 is a clinical study titled "Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula". Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days...
What is the current status of trial NCT03236207?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2017-07-06. Estimated completion is 2018-11-06.
What conditions does trial NCT03236207 study?
This clinical trial studies the following conditions: Cow Milk Allergy.
What interventions are being tested in trial NCT03236207?
The interventions under investigation include: Test extensively hydrolyzed formula (OTHER), Control extensively hydrolyzed formula (OTHER).
Who is sponsoring clinical trial NCT03236207?
This trial is sponsored by Société des Produits Nestlé (SPN), which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03236207 being conducted?
This trial has 12 study locations across California, Minnesota, Missouri, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03236207's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 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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