NCT03236207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

July 19, 2017

Last Update Submit

January 28, 2019

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • allergic reaction post DBPCFC

    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

    2 hours

Secondary Outcomes (3)

  • stool characteristics

    1 week

  • formula intake

    1 week

  • adverse events

    1 week

Study Arms (2)

Test infant formula

EXPERIMENTAL

Test non-commercial extensively hydrolyzed infant formula with HMOs

Other: Test extensively hydrolyzed formula

Control infant formula

ACTIVE COMPARATOR

Control non-commercial extensively hydrolyzed infant formula without HMOs

Other: Control extensively hydrolyzed formula

Interventions

Test extensively hydrolyzed formulaOTHER

extensively hydrolyzed formula with HMOs

Test infant formula
Control extensively hydrolyzed formulaOTHER

extensively hydrolyzed formula without HMOs

Control infant formula

Eligibility Criteria

Age2 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born at term (\>36 weeks gestation)
  • months to \<4 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Having obtained his/her legal representative's informed consent

You may not qualify if:

  • Any chromosomal or major congenital anomalies
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
  • Immunodeficiency
  • Anaphylaxis to any food
  • Receiving free amino acid formula
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • Currently participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hoag Medical Group

Huntington Beach, California, 92648, United States

Location

Stanford University

Mountain View, California, 94040, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

Midwest Clinical Research

St Louis, Missouri, 63141, United States

Location

Breathe America

Albuquerque, New Mexico, 87109, United States

Location

Northwell Health System

Great Neck, New York, 11021, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 71320, United States

Location

Carolina ENT

Orangeburg, South Carolina, 29118, United States

Location

Memphis & Shelby County Pediatrics

Memphis, Tennessee, 38116, United States

Location

Houston Clinical Research Associates

Houston, Texas, 77090, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76633, United States

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anna Nowak-Wegrzyn, MD

    Mt Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

August 1, 2017

Study Start

July 6, 2017

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(12)