Althera® Versus Nutramigen / Cow's Milk Intolerance

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727115
• Other study ID #: 06.04.INF
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 12, 2012
• Start date: April 2008
• Est. completion date: July 2011

Study information

• Verified date: November 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy
• Lactose Intolerance

Intervention

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

Locations

Country	Name	City	State
Belgium	ASZ	Aalst
Belgium	ZNA Middelheim	Antwerp
Belgium	AZ VUB	Brussels
Belgium	CHU Huderf	Brussels
Belgium	Cliniques Universitaires	Brussels
Belgium	Az Maria Middelares	Gent
Belgium	UZ Gent Pediatrie	Gent
Belgium	Clinique de l'Espérance	Montegnée
Belgium	Centre Hospitalier Regional	Namur
Belgium	Clinique Saint Pierre	Ottignies
Belgium	Maria Ziekenhuis	Overpelt
Belgium	Az Vesalius	Tongeren
Belgium	CH WAPI Tournai	Tournai
Belgium	Sint Augustinus	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess whether the 2 groups have comparable changes in weight, length and head circumference	weight, length, head circumference	1 year	Yes