NCT01727115

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

2.5 years

First QC Date

November 12, 2012

Last Update Submit

November 12, 2012

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

NUTRAMIGEN®

ACTIVE COMPARATOR

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

ALTHERA®

EXPERIMENTAL

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

Interventions

Infant Formula FeedingOTHER

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

ALTHERA®NUTRAMIGEN®

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

ASZ

Aalst, Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, Antwerp, 2020, Belgium

Location

CHU Huderf

Brussels, Brussels Capital, 1020, Belgium

Location

AZ VUB

Brussels, Brussels Capital, 1090, Belgium

Location

Cliniques Universitaires

Brussels, Brussels Capital, 1200, Belgium

Location

Az Maria Middelares

Ghent, Gent, 9000, Belgium

Location

UZ Gent Pediatrie

Ghent, Gent, 9000, Belgium

Location

Clinique de l'Espérance

Montegnée, Montegnée, 4420, Belgium

Location

Centre Hospitalier Regional

Namur, Namur, 5000, Belgium

Location

Clinique Saint Pierre

Ottignies, Ottignies, 1340, Belgium

Location

Maria Ziekenhuis

Overpelt, Overpelt, 3900, Belgium

Location

Az Vesalius

Tongeren, Tongeren, 3700, Belgium

Location

CH WAPI Tournai

Tournai, Tournai, 7500, Belgium

Location

Sint Augustinus

Wilrijk, Wilrijk, 2610, Belgium

Location

Related Publications (1)

  • Vandenplas Y, Steenhout P, Planoudis Y, Grathwohl D; Althera Study Group. Treating cow's milk protein allergy: a double-blind randomized trial comparing two extensively hydrolysed formulas with probiotics. Acta Paediatr. 2013 Oct;102(10):990-8. doi: 10.1111/apa.12349. Epub 2013 Aug 5.

    PMID: 23837862DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • 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

    Algemeen Ziekenhuis Maria Middelares

    PRINCIPAL INVESTIGATOR

  • Michèle Scaillon, Doctor

    CHU des Enfants Reine Fabiola

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 15, 2012

Study Start

April 1, 2008

Primary Completion

October 1, 2010

Study Completion

July 1, 2011

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

BE(14)