Althera® Versus Nutramigen / Cow's Milk Intolerance

Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance

The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Other: Infant Formula Feeding

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • ASZ
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Brussels, Belgium, 1020
    • CHU Huderf
  • Brussels, Belgium, 1090
    • AZ VUB
  • Brussels, Belgium, 1200
    • Cliniques Universitaires
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Gent, Belgium, 9000
    • UZ Gent Pediatrie
  • Montegnée, Belgium, 4420
    • Clinique de l'Esperance
  • Namur, Belgium, 5000
    • Centre Hospitalier Régional
  • Ottignies, Belgium, 1340
    • Clinique Saint Pierre
  • Overpelt, Belgium, 3900
    • Maria Ziekenhuis
  • Tongeren, Belgium, 3700
    • AZ Vesalius
  • Tournai, Belgium, 7500
    • CH WAPI Tournai
  • Wilrijk, Belgium, 2610
    • Sint Augustinus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants from few days of life until 6 months of age
• Birth weight : between 2.500g and 4.500g
• Full term: gestational age between 37 and 42 weeks
• Singleton birth
• Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
• Having obtained the Informed Consent by the Parents or the legal guardian

Exclusion Criteria:

• Exclusive breastfeeding at time of enrolment
• Having been treated before enrolment with an extensively hydrolysed formula
• Disease impairing a normal gut transit (like pyloric stenosis)
• Intolerance to lactose (if already known)
• Receiving an antibiotic treatment at the time of enrolment
• Severe or chronic diarrhea
• Failure to thrive
• Neurologic diseases
• Receiving a medical treatment which could interfere with the protocol or after a surgical intervention
• Infants whose parents / caregivers who cannot be expected to comply with treatment
• Currently participating or having participated in another interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NUTRAMIGEN®; Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Nutramigen® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Nutramigen®; If the test is negative: A Follow up formula is given(Nan pro2) if child > 6 months(Nan pro1) if child < 6 months	Other: Infant Formula Feeding; Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.; If the challenge is positive: The children continue the assigned formula; If the challenge is negative: A Follow up formula is given(Nan pro2) if child > 6 months(Nan pro1) if child < 6 months
Experimental: ALTHERA®; Subjects are orally fed ad libitum (following guidelines printed on the labels). Subjects will receive the Althera® formula for a 4 week period Then depending of the result of the challenge test we have the following possibilities: If the test is positive: The children continue the formula Althera®; If the test is negative: A Follow up formula is given(Nan pro2) if child > 6 months(Nan pro1) if child < 6 months	Other: Infant Formula Feeding; Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.; If the challenge is positive: The children continue the assigned formula; If the challenge is negative: A Follow up formula is given(Nan pro2) if child > 6 months(Nan pro1) if child < 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.	regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess whether the 2 groups have comparable changes in weight, length and head circumference	weight, length, head circumference	1 year

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Yvan Vandenplas, Professor, AZ-Kinderen V.U.B.; Principal Investigator: Bruno Hauser, Doctor, AZ-Kinderen V.U.B.; Principal Investigator: Thierry Devreker, Doctor, AZ-Kinderen V.U.B.; Principal Investigator: Marc Verghote, Doctor, CHR Namur; Principal Investigator: Christine Halut, Doctor, CHR Namur; Principal Investigator: Olivia Bauraind, Doctor, Clinique Saint Pierre; Principal Investigator: Sandra Mulier, Doctor, CHU des Enfants Reine Fabiola; Principal Investigator: Pascal Lenoir, Doctor, Clinique Notre Dame Tournai; Principal Investigator: Etienne Sokal, Professor, Clinique Universitaire Saint Luc; Principal Investigator: Francoise Smets, Doctor, Clinique Universitaire Saint Luc; Principal Investigator: Francoise Bury, Doctor, Clinique de l'Esperance; Principal Investigator: Stéphanie Colinet, Doctor, Clinique de l'Esperance; Principal Investigator: Stefaan Peeters, Doctor, Aalsters Stedelijk ziekenhuis; Principal Investigator: Patrick Bollen, Doctor, AZ Vesalius; Principal Investigator: Paul Mariën, Doctor, Sint Augustinus; Principal Investigator: Gigi Veereman, Professor, Paola Kinderziekenhuis; Principal Investigator: Myriam VanWinckel, Professor, UZ Gent; Principal Investigator: Jozef Christens, Doctor, Maria Ziekenhuis Noord Limburg; Principal Investigator: Kristien Kamoen, doctor, Algemeen Ziekenhuis Maria Middelares; Principal Investigator: Michèle Scaillon, Doctor, CHU des Enfants Reine Fabiola

Publications and helpful links

General Publications

• Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Estimate): November 15, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: 06.04.INF