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Althera® Versus Nutramigen / Cow's Milk Intolerance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01727115
First received: November 12, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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


Condition Intervention
Allergy
 Other: Infant Formula Feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Extensively Hydrolyzed Formulas for the Treatment of Children With Cow's Milk Intolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • The primary outcome are regurgitations/vomiting, stool consistency, atopic eczema, urticaria and respiratory symptoms after 4 weeks of treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    weight, length, head circumference


Enrollment: 116
Study Start Date: April 2008
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NUTRAMIGEN®

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
 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
Other Name: Infant formula feeding
Experimental: ALTHERA®

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
 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
Other Name: Infant formula feeding

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727115

Locations
Belgium
ASZ
Aalst, Belgium, 9300
ZNA Middelheim
Antwerp, Belgium, 2020
AZ VUB
Brussels, Belgium, 1090
CHU Huderf
Brussels, Belgium, 1020
Cliniques Universitaires
Brussels, Belgium, 1200
Az Maria Middelares
Gent, Belgium, 9000
UZ Gent Pediatrie
Gent, Belgium, 9000
Clinique de l'Espérance
Montegnée, Belgium, 4420
Centre Hospitalier Regional
Namur, Belgium, 5000
Clinique Saint Pierre
Ottignies, Belgium, 1340
Maria Ziekenhuis
Overpelt, Belgium, 3900
Az Vesalius
Tongeren, Belgium, 3700
CH WAPI Tournai
Tournai, Belgium, 7500
Sint Augustinus
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Yvan Vandenplas, Professor AZ-Kinderen V.U.B.
Principal Investigator: Bruno Hauser, Doctor AZ-Kinderen V.U.B.
Principal Investigator: Thierry Devreker, Doctor AZ-Kinderen V.U.B.
Principal Investigator: Marc Verghote, Doctor CHR Namur
Principal Investigator: Christine Halut, Doctor CHR Namur
Principal Investigator: Olivia Bauraind, Doctor Clinique Saint Pierre
Principal Investigator: Sandra Mulier, Doctor CHU des Enfants Reine Fabiola
Principal Investigator: Pascal Lenoir, Doctor Clinique Notre Dame Tournai
Principal Investigator: Etienne Sokal, Professor Clinique Universitaire Saint Luc
Principal Investigator: Francoise Smets, Doctor Clinique Universitaire Saint Luc
Principal Investigator: Francoise Bury, Doctor Clinique de l'Espérance
Principal Investigator: Stéphanie Colinet, Doctor Clinique de l'Espérance
Principal Investigator: Stefaan Peeters, Doctor Aalsters Stedelijk ziekenhuis
Principal Investigator: Patrick Bollen, Doctor AZ Vesalius
Principal Investigator: Paul Mariën, Doctor Sint Augustinus
Principal Investigator: Gigi Veereman, Professor Paola Kinderziekenhuis
Principal Investigator: Myriam VanWinckel, Professor UZ Gent
Principal Investigator: Jozef Christens, Doctor Maria Ziekenhuis Noord Limburg
Principal Investigator: Kristien Kamoen, doctor AZ Maria Middelares
Principal Investigator: Michèle Scaillon, Doctor CHU des Enfants Reine Fabiola
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01727115     History of Changes
Other Study ID Numbers: 06.04.INF
Study First Received: November 12, 2012
Last Updated: November 12, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013