At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 100 enrolled

Drug / intervention

Baked Milkdietary

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02738060

NCT02738060Phase 2Completed

Compare CT.gov

Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy

Hossein Esmaielzadeh·interventional·Posted Apr 14, 2016·Updated Apr 25, 2018

In Brief

A Phase 2 clinical trial evaluating Baked Milk for Cow's Milk Allergy. Completed, enrolled 100 participants across 1 site.

Detailed Summary

To investigate the effect of baked milk in immunotherapy of cow's milk allergy.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCow's Milk Allergy

CountriesIran

CollaboratorsShiraz University of Medical Sciences

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartSep 2015

First PostedApr 2016

Primary CompletionMar 2017

Study CompletionApr 2017

TodayJul 2026

First PostedApr 14, 2016

Enrollment StartSep 1, 2015

Primary CompletionMar 1, 2017

Study CompletionApr 1, 2017

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 10.2 years ago

Interventions

Baked Milkdietary

The patients in case group will be received baked milk daily in the form of muffin(30 cc milk (equal to 1/3 of milk's proteins) heated in 350 F or 180 C for 30 mints) for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period. Skin prick test and serum IgE levels will be done at the beginning of the study, at 6 and 12 months. IgG4, being specific for milk allergens, will also measured at the beginning and at 12 months of the study.