Efficacy of a New Thickened Extensively Hydrolyzed Formula
ALLAR
Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
1 other identifier
interventional
72
5 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 8, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 24, 2015
March 1, 2015
2.4 years
November 8, 2013
March 20, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patient dropped out for intolerance
1 month
Vandenplas' regurgitations score
1 month
Secondary Outcomes (5)
Cow's milk protein hypersensitivity score
1 month
Growth (weight, height, head circumference)
1 month
Growth (weight, height, head circumference)
3 months
Growth (weight, height, head circumference)
6 months
Number of daily regurgitations
1 month
Study Arms (2)
Thickened
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Exclusively breast fed infants
- Fed with an extensively hydrolysed formula or amino acid formula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Universitair Ziekenhuis Brussel
Brussels, Belgium
Hippocration Hospital
Thessaloniki, Greece
Faculty of Medicine, Kuwait university
Safat, Kuwait
Pediatricians
Beirut, Lebanon
University Children's Hospital
Ljubljana, Slovenia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 15, 2013
Study Start
February 1, 2011
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
March 24, 2015
Record last verified: 2015-03