Clinical trial NCT01727115: Althera® Versus Nutramigen / Cow's Milk Intolerance
Official title: Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 116
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: To assess whether the 2 groups have comparable changes in weight, length and head circumference
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: CHU Huderf
city: Brussels
country: Belgium
facility: AZ VUB
city: Brussels
country: Belgium
facility: Cliniques Universitaires
city: Gent
country: Belgium
facility: Az Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent Pediatrie
city: Montegnée
country: Belgium
facility: Clinique de l'Espérance
city: Namur
country: Belgium
facility: Centre Hospitalier Regional
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Overpelt
country: Belgium
facility: Maria Ziekenhuis
city: Tongeren
country: Belgium
facility: Az Vesalius
city: Tournai
country: Belgium
facility: CH WAPI Tournai
city: Wilrijk
country: Belgium
facility: Sint Augustinus
Study officials:
affiliation: AZ-Kinderen V.U.B.
name: Yvan Vandenplas, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ-Kinderen V.U.B.
name: Bruno Hauser, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ-Kinderen V.U.B.
name: Thierry Devreker, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Namur
name: Marc Verghote, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR Namur
name: Christine Halut, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Saint Pierre
name: Olivia Bauraind, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU des Enfants Reine Fabiola
name: Sandra Mulier, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Notre Dame Tournai
name: Pascal Lenoir, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Universitaire Saint Luc
name: Etienne Sokal, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Universitaire Saint Luc
name: Francoise Smets, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique de l'Espérance
name: Francoise Bury, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique de l'Espérance
name: Stéphanie Colinet, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalsters Stedelijk ziekenhuis
name: Stefaan Peeters, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Vesalius
name: Patrick Bollen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint Augustinus
name: Paul Mariën, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Paola Kinderziekenhuis
name: Gigi Veereman, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Myriam VanWinckel, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Maria Ziekenhuis Noord Limburg
name: Jozef Christens, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Kristien Kamoen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU des Enfants Reine Fabiola
name: Michèle Scaillon, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.