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An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Nutricia Liverpool.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nutricia Liverpool
ClinicalTrials.gov Identifier:
NCT01109966
First received: March 29, 2010
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.


Condition Intervention Phase
Allergy
Food Allergy
Other: Special Medical Food
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)

Resource links provided by NLM:


Further study details as provided by Nutricia Liverpool:

Primary Outcome Measures:
  • To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: June 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amino acid based formula

Patients will be randomised to one of two arms:

Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula

Other: Special Medical Food

Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.

Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age.

Other Name: Amino acid based formula, Neocate LCP
Active Comparator: New amino acid based formula

Patients will be randomised to one of two arms:

Group I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula

Other: Special Medical Food

Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.

Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age.

Other Name: Amino acid based formula

Detailed Description:

Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development.

  Eligibility

Ages Eligible for Study:   up to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants ≤ 8 months of age
  • Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months

Exclusion Criteria:

  • Infants less than 2500 g at birth
  • Infants less than 37 weeks gestation
  • Infants with severe concurrent illness
  • Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs
  • Infants consuming less than 500ml per day of their usual formula at study entry
  • Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109966

Locations
France
l'hôpital Necker Enfants malades Not yet recruiting
Paris, France, 75743
Contact: Christophe Dupont, Prof.       christophe.dupont@nck.aphp.fr   
Principal Investigator: Christophe Dupont, Prof. (MD)         
Germany
Hospital Charité Recruiting
Berlin, Germany, D-13353
Contact: Kirsten Beyer, PD Dr med    +49-(0)30-450 566037    kirsten.beyer@charite.de   
Principal Investigator: Kirsten Beyer, MD         
St.-Marien-Hospital Recruiting
Bonn, Germany, 53115
Contact: Lars Lange, MD       Lars.Lange@marien-hospital-bonn.de   
Principal Investigator: Lars Lange, MD         
United Kingdom
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Mich Lajeunesse, MD       mich.lajeunesse@soton.ac.uk   
Principal Investigator: Mich Lajeunesse, MD         
Sub-Investigator: Louise Michaelis, MD         
David Hyde Allergy Clinic - St. Mary's hospital Recruiting
Newport, Isle of Wight, United Kingdom, PO30 5TG
Contact: Graham Roberts, MD       g.c.roberts@soton.ac.uk   
Principal Investigator: Graham Roberts, MD         
Evelina Children's Hospital - St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Adam Fox, MD       adam.fox@gstt.nhs.uk   
Principal Investigator: Adam Fox, MD         
Newcastle general hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE4 6BE
Contact: Gillian Vance, MD       Gillian.Vance@nuth.nhs.uk   
Principal Investigator: Gillian Vance, MD         
Sponsors and Collaborators
Nutricia Liverpool
Investigators
Principal Investigator: Kirsten Beyer, MD Hospital Charité
  More Information

No publications provided

Responsible Party: Research and Development, Nutricia Liverpool
ClinicalTrials.gov Identifier: NCT01109966     History of Changes
Other Study ID Numbers: CT0140PAICE
Study First Received: March 29, 2010
Last Updated: July 21, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Nutricia Liverpool:
Allergy
Cow's Milk
Infants
Food Allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 24, 2014