NCT00664768

Brief Summary

This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA. This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

22 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

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

4.3 years

First QC Date

April 21, 2008

Last Update Submit

December 7, 2020

Conditions

Cow Milk Allergy

Keywords

hypoallergenicityCow Milk AllergyDBPCFCStool microfloraStool characteristics

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.

    The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. Length and head circumference measures will also be collected and analysed. Both the growth velocities of the group as a whole (cross-sectional group data) and individuals (longitudinal individual data) will be reviewed and analysed. In assessing group data, comparisons of increments per unit of time will be made. Due to the varying ages of the subjects recruited to the study, growth measures will be concerted to z-scores using an appropriate reference population to allow a meaningful comparison of the ability of the formulas to promote growth. In assessing the growth of individual infants, data will be plotted on National Centre for Health Statistics (NCHS) growth charts and assessed qualitatively.

    4 months

Study Arms (2)

New Neocate

EXPERIMENTAL

new Neocate

Dietary Supplement: new Neocate

Neocate Infant

ACTIVE COMPARATOR

Neocate Infant formula

Dietary Supplement: Neocate Infant

Interventions

Neocate InfantDIETARY_SUPPLEMENT

minimum of 8 fl. oz daily

Neocate Infant
new NeocateDIETARY_SUPPLEMENT

minimum of 8 fl oz daily

New Neocate

Eligibility Criteria

Age1 Day - 8 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
  • Positive double-blind placebo controlled food challenge with cow milk
  • A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
  • Confirmed history of a reaction to cow milk protein with CM-specific IgE of \>15kU/L for children over two years and \> 5kU/L for children under two years.
  • Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
  • No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
  • For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
  • Written informed consent / ability to give informed consent.
  • These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,

You may not qualify if:

  • All subjects
  • Infants \<5lb 8oz at birth
  • Infants \< 37 weeks gestation
  • Infants with severe concurrent illness or major congenital malformations
  • Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
  • Unable to adhere to protocol instructions due to non compliance of parent or caregiver
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  • Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
  • An infant of any personnel connected with the study
  • Infants whose parent/caregiver is younger than the legal age of consent
  • These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pendleton Pediatrics

Chandler, Arizona, 85224, United States

Location

Visions Clinical Research - Tucson

Tucson, Arizona, 85712, United States

Location

Children's Investigational Research Program, LLC (CHIRP)

Bentonville, Arkansas, 72712, United States

Location

Children's Hospital, LA

Los Angeles, California, 90027, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Rosario B. Retino, MD, Inc

Ontario, California, 91762, United States

Location

Choc Psf, Amc

Orange, California, 92868, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Alzein Pediatrics

Evergreen Park, Illinois, 60805, United States

Location

Regional Research Specialists, LLC

Shreveport, Louisiana, 71106, United States

Location

Craig A. Spiegel, M.D.

Bridgeton, Missouri, 63044, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Asheboro Research Associates

Asheboro, North Carolina, 27203, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Pediatrics, PLLC

Holly Springs, North Carolina, 27540, United States

Location

John Panuto, M.D.

Middleburg Heights, Ohio, 44130, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Related Publications (3)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

  • Harvey BM, Eussen SRBM, van Helvoort A, Harthoorn LF. Cow's Milk Allergic Infants on Elemental Formula Maintain Adequate Mineral Status Despite Using Acid-suppressive Drugs. J Pediatr Gastroenterol Nutr. 2019 Nov;69(5):e147-e148. doi: 10.1097/MPG.0000000000002469. No abstract available.

    PMID: 31425366DERIVED

  • Burks AW, Harthoorn LF, Van Ampting MT, Oude Nijhuis MM, Langford JE, Wopereis H, Goldberg SB, Ong PY, Essink BJ, Scott RB, Harvey BM. Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. Pediatr Allergy Immunol. 2015 Jun;26(4):316-22. doi: 10.1111/pai.12390.

    PMID: 25845680DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Barbara Mourmans

    Study Mgr Nutricia Research - Centre for Specialised Nutrition

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 9, 2020

Record last verified: 2020-12

Locations

US(22)