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A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy (CMA)

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neocate Infant
new Neocate
Sponsored by
Nutricia North America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy focused on measuring hypoallergenicity, Cow Milk Allergy, DBPCFC, Stool microflora, Stool characteristics

Eligibility Criteria

1 Day - 8 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Written informed consent / ability to give informed consent.
  3. 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,

Exclusion Criteria:

All subjects

  1. Infants <5lb 8oz at birth
  2. Infants < 37 weeks gestation
  3. Infants with severe concurrent illness or major congenital malformations
  4. Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
  5. Unable to adhere to protocol instructions due to non compliance of parent or caregiver
  6. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  7. Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
  8. An infant of any personnel connected with the study
  9. Infants whose parent/caregiver is younger than the legal age of consent
  10. For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
  11. These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.

Sites / Locations

  • Pendleton Pediatrics
  • Visions Clinical Research - Tucson
  • Children's Investigational Research Program, LLC (CHIRP)
  • Children's Hospital, LA
  • David Geffen School of Medicine at UCLA
  • Rosario B. Retino, MD, Inc
  • Choc Psf, Amc
  • Nemours Children's Clinic
  • Alzein Pediatrics
  • Regional Research Specialists, LLC
  • Craig A. Spiegel, M.D.
  • Meridian Clinical Research, LLC
  • Weill Cornell Medical College
  • Asheboro Research Associates
  • Duke University
  • Pediatrics, PLLC
  • John Panuto, M.D.
  • The Children's Hospital of Philadelphia
  • Childrens Hospital of Pittsburgh
  • PI-Coor Clinical Research, LLC
  • Virginia Commonwealth University
  • Advanced Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New Neocate

Neocate Infant

Arm Description

new Neocate

Neocate Infant formula

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
December 7, 2020
Sponsor
Nutricia North America
Collaborators
Nutricia Liverpool, Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT00664768
Brief Title
A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
Acronym
CMA
Official Title
A Prospective, Randomized, DB Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia North America
Collaborators
Nutricia Liverpool, Danone Institute International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Infants who qualify will begin a 7-day milk protein elimination diet that excludes all milk or products which contain milk. Parents will be asked to keep a food diary of everything the child eats during the week following the Screening Visit. During this week, the child can continue to drink their current hypoallergenic formula. Subjects will be assessed at seven study visits at baseline, two weeks, four weeks and then monthly until the end of the study period, where the following will be assessed: Study Visit 1 (Day -7): Baseline This will be carried out at entry to the trial to collect baseline data; at this visit subjects will under go the following assessments: Assess Patient suitability Obtain Informed Consent Obtain Subject number Perform physical exam and clinical assessment Medical history and assessment including SCORing Atopic Dermatitis assessment (SCORAD) Obtain weight, length and head circumference Collect a 9ml venous blood sample The following is to analysed by the central lab; Plasma total protein/albumin and prealbumin Blood urea nitrogen, electrolytes and creatinine Complete blood count with differential Alkaline phosphatase. Serum Iron, Total Iron Binding Capacity and Ferritin Plasma fatty acid analysis Provide stool lab kits and explain to parent/caregiver how to collect stool sample during the pre-evaluation week Provide one-week subject diary (Subject Diary 1) and instruct parent/caregiver on how to complete record, clinical symptoms and stool characteristics (frequency, consistency and color) in subject diary. Provide the one-week Food Frequency Diary A and instruct the parent/caregiver on how to complete this assessment Provide information on following a milk protein exclusion diet, with or without the exclusion of other allergenic food proteins as advised by the subject's physician Record all concomitant medications taken within two weeks prior to the Baseline Visit Study Visit 2 (Day 0): Once subjects have completed the pre-evaluation period subjects will undergo the following assessment: Review Subject Diary 1 and Food Frequency Diary A, for study compliance Randomisation assignment to one of the two study formulas Perform physical exam and clinical assessment Obtain weight, length/height and head circumference Provide two-week subject diary (Subject Diary 2a) and instruct parent/caregiver on how to record clinical symptoms and stool characteristics in subject diary. Provide the one-week Food Frequency Diary B and instruct the parent/caregiver on how to complete this assessment Collect stool sample that was obtained in previous week at home Phone review (Day 7) Subjects will be reviewed at this time point by telephone to review if any clinical symptoms have occurred while ingesting study formula. If it is determined by the Principal Investigator that the subject has had any clinically significant reaction(s) to the study formula, the subject must return to the clinic for evaluation. Subjects will progress to Phase II and continue feeding with the formula they have consumed as part of the seven-day, post-challenge feeding period. Study Visit 3 (Day 14): Two weeks on formula Once subjects have been consuming their assigned formula for a two week period the following assessment will be carried out: Obtain weight, length and head circumference Collect Subject Diary 2a and Food Frequency Diary B Review of open feeding period and presence of any clinical symptoms Provide one-week subject diary (Subject Diary 3) to be completed the week before returning for Visit 4 and instruct parent/caregiver on how to record, clinical symptoms and stool characteristics in subject diary. Provide three-day Food Diary 1 to be completed the week before returning for visit 4 and instruct parent/caregiver on how to complete the food records Instruct parent to collect stool sample during the week before study Visit 4. Review study product requirement and dispense as necessary Study Visit 4 (Day 28): One month on formula Once subject have been consuming test formula for one month they will undergo the following assessment: Perform clinical assessment and SCORAD Obtain weight, length and head circumference Obtain stool sample collected by parent Collect and review Subject Diary 3 and Food Diary 1 Review study product requirement and dispense as necessary Study Visit 5 (Day 56): Two months on formula Obtain weight, length and head circumference Provide 3 day subject diary (Subject Diary 4) to be completed in the following week and instruct parent/caregiver on how to record clinical symptoms and stool characteristics in subject diary Provide three-day Food Diary 2 to be completed in the following week and instruct parent/caregiver on how to complete the food records Review study product requirement and dispense as necessary Study Visit 6 (Day 84): Three months on formula Obtain weight, length and head circumference Collect Subject Diary 4 and Food Diary 2 Provide one week subject diary (Subject Diary 5) to be completed in the week prior to the final study visit and instruct parent/caregiver on how to complete the food records, clinical symptoms and stool characteristics in subject diary Provide three-day Food Diary 3 to be completed in the week prior to the final study visit and instruct parent/caregiver on how to complete the food records Instruct parent to take stool sample during the week before the final study visit Review study product requirement and dispense as necessary Study Visit 7 (Day 112): Final visit - four months on formula or Early Termination Perform clinical assessment and SCORAD Obtain weight, length and head circumference Obtain stool sample collected by parent Collect and review Subject Diary 5 and Food Diary 3 Collect blood sample Ensure Parents/caregivers have returned all diaries to the appropriate clinician at each center Study personnel will review the forms with the parents/caregivers Parents/caregivers will return all partial and unopened cans of the test formula

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy
Keywords
hypoallergenicity, Cow Milk Allergy, DBPCFC, Stool microflora, Stool characteristics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Neocate
Arm Type
Experimental
Arm Description
new Neocate
Arm Title
Neocate Infant
Arm Type
Active Comparator
Arm Description
Neocate Infant formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Neocate Infant
Intervention Description
minimum of 8 fl. oz daily
Intervention Type
Dietary Supplement
Intervention Name(s)
new Neocate
Intervention Description
minimum of 8 fl oz daily
Primary Outcome Measure Information:
Title
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, Exclusion Criteria: 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 For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period. These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Mourmans
Organizational Affiliation
Study Mgr Nutricia Research - Centre for Specialised Nutrition
Official's Role
Study Director
Facility Information:
Facility Name
Pendleton Pediatrics
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Visions Clinical Research - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Children's Investigational Research Program, LLC (CHIRP)
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Children's Hospital, LA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rosario B. Retino, MD, Inc
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Choc Psf, Amc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Alzein Pediatrics
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Regional Research Specialists, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Craig A. Spiegel, M.D.
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheboro Research Associates
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pediatrics, PLLC
City
Holly Springs
State/Province
North Carolina
ZIP/Postal Code
27540
Country
United States
Facility Name
John Panuto, M.D.
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Childrens Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
PI-Coor Clinical Research, LLC
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Advanced Pediatrics
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33006765
Citation
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.
Results Reference
derived
PubMed Identifier
31425366
Citation
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.
Results Reference
derived
PubMed Identifier
25845680
Citation
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.
Results Reference
derived

Learn more about this trial

A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy

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