Althera® Versus Nutramigen / Cow's Milk… | Clinical Trial

Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASZ, Aalst, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant Formula Feeding

Other

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

Primary outcomes

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

Time frame: 4 weeks

regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms

Secondary outcomes

To assess whether the 2 groups have comparable changes in weight, length and head circumference

Time frame: 1 year

weight, length, head circumference

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Nov 15, 2012
Registry last updated: Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed