An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
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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) |
- 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 ]
- 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 |
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| 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 | |
| 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:
|
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 23, 2013