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Althera® Versus Nutramigen / Cow's Milk Intolerance

Primary Purpose

Allergy

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Infant Formula Feeding

About this trial

This is an interventional treatment trial for Allergy

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NUTRAMIGEN®

ALTHERA®

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

weight, length, head circumference

Full Information

NCT ID

NCT01727115

First Posted

November 12, 2012

Last Updated

November 12, 2012

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT01727115

Brief Title

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

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NUTRAMIGEN®

Arm Type

Active Comparator

Arm Description

Arm Title

ALTHERA®

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Infant Formula Feeding

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

weight, length, head circumference

Time Frame

1 year

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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

Overall Study Officials: