Althera® Versus Nutramigen / Cow's Milk Intolerance

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727115

Enrollment

116

Registered

2012-11-15

Start date

2008-04-30

Completion date

2011-07-31

Last updated

2012-11-15

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

Conditions

Allergy

Brief summary

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

Interventions

OTHERInfant 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium

Outcome results

None listed

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