NCT01109966

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
3 countries

7 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 29, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

March 29, 2010

Last Update Submit

May 4, 2017

Conditions

AllergyFood Allergy

Keywords

AllergyCow's MilkInfantsFood Allergy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.

    2 years

Secondary Outcomes (1)

  • 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

    2 years

Study Arms (2)

Amino acid based formula

ACTIVE COMPARATOR

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

New amino acid based formula

ACTIVE COMPARATOR

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

Interventions

Special Medical FoodOTHER

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.

Also known as: Amino acid based formula, Neocate LCP
Amino acid based formula

Eligibility Criteria

AgeUp to 8 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

l'hôpital Necker Enfants malades

Paris, 75743, France

Location

Hospital Charité

Berlin, D-13353, Germany

Location

St.-Marien-Hospital

Bonn, 53115, Germany

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

David Hyde Allergy Clinic - St. Mary's hospital

Newport, Isle of Wight, PO30 5TG, United Kingdom

Location

Evelina Children's Hospital - St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Newcastle general hospital

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Study Officials

  • Kirsten Beyer, MD

    Hospital Charité

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2010

First Posted

April 23, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)DE(2)FR(1)