Efficacy of a New Thickened Extensively Hydrolyzed Formula

Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01985607

Acronym

ALLAR

Enrollment

Registered

2013-11-15

Start date

2011-02-28

Completion date

2013-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Protein Hypersensitivity, Protein Allergy

Brief summary

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) & the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate . This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.

Interventions

DIETARY_SUPPLEMENTnew extensively hydrolysed formula

DIETARY_SUPPLEMENTExtensively hydrolysed formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Inclusion criteria

* term born infants * Having a Vandenplas' score of regurgitation of at least 2 * With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion criteria

* Exclusively breast fed infants * Fed with an extensively hydrolysed formula or amino acid formula

Design outcomes

Primary

Measure	Time frame
Number of patient dropped out for intolerance	1 month
Vandenplas' regurgitations score	1 month

Secondary

Measure	Time frame
Cow's milk protein hypersensitivity score	1 month
Growth (weight, height, head circumference)	1 month
Number of daily regurgitations	1 month

Countries

Belgium, Greece, Kuwait, Lebanon, Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026