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NCT02397876 · ClinicalTrials.gov registry record · NA

Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT02397876: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT02397876 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02397876, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.

Primary Outcome

Prevalence of partially hydrolyzed whey formula tolerance in cow's milk allergic patients - Identify patients who are cow's milk allergic but can tolerate a partially hydrolyzed whey formula

Interventions

  • OTHER Partially Hydrolyzed Whey formula

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-03
Est. Completion 2016-06
Phase NA

What the finished NCT02397876 record still lists

NCT02397876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Partially Hydrolyzed Whey formula is the first listed.

NCT02397876 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02397876 about?

NCT02397876 is a clinical study titled "Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients". Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM all...

What is the current status of trial NCT02397876?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2015-03. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02397876?

The interventions under investigation include: Partially Hydrolyzed Whey formula (OTHER).

Who is sponsoring clinical trial NCT02397876?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02397876's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 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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Source: ClinicalTrials.gov NCT02397876, the US trial registry maintained by the National Library of Medicine. NCT02397876 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.