Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
116 participants
INTERVENTIONAL
2008-04-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
6 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yvan Vandenplas, Professor
Role: PRINCIPAL_INVESTIGATOR
AZ-Kinderen V.U.B.
Bruno Hauser, Doctor
Role: PRINCIPAL_INVESTIGATOR
AZ-Kinderen V.U.B.
Thierry Devreker, Doctor
Role: PRINCIPAL_INVESTIGATOR
AZ-Kinderen V.U.B.
Marc Verghote, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHR Namur
Christine Halut, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHR Namur
Olivia Bauraind, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Saint Pierre
Sandra Mulier, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHU des Enfants Reine Fabiola
Pascal Lenoir, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Notre Dame Tournai
Etienne Sokal, Professor
Role: PRINCIPAL_INVESTIGATOR
Clinique Universitaire Saint Luc
Francoise Smets, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Universitaire Saint Luc
Francoise Bury, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique de l'Espérance
Stéphanie Colinet, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique de l'Espérance
Stefaan Peeters, Doctor
Role: PRINCIPAL_INVESTIGATOR
Aalsters Stedelijk ziekenhuis
Patrick Bollen, Doctor
Role: PRINCIPAL_INVESTIGATOR
AZ Vesalius
Paul Mariën, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sint Augustinus
Gigi Veereman, Professor
Role: PRINCIPAL_INVESTIGATOR
Paola Kinderziekenhuis
Myriam VanWinckel, Professor
Role: PRINCIPAL_INVESTIGATOR
UZ Gent
Jozef Christens, Doctor
Role: PRINCIPAL_INVESTIGATOR
Maria Ziekenhuis Noord Limburg
Kristien Kamoen, doctor
Role: PRINCIPAL_INVESTIGATOR
Algemeen Ziekenhuis Maria Middelares
Michèle Scaillon, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHU des Enfants Reine Fabiola
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASZ
Aalst, Aalst, Belgium
ZNA Middelheim
Antwerp, Antwerp, Belgium
CHU Huderf
Brussels, Brussels Capital, Belgium
AZ VUB
Brussels, Brussels Capital, Belgium
Cliniques Universitaires
Brussels, Brussels Capital, Belgium
Az Maria Middelares
Ghent, Gent, Belgium
UZ Gent Pediatrie
Ghent, Gent, Belgium
Clinique de l'Espérance
Montegnée, Montegnée, Belgium
Centre Hospitalier Regional
Namur, Namur, Belgium
Clinique Saint Pierre
Ottignies, Ottignies, Belgium
Maria Ziekenhuis
Overpelt, Overpelt, Belgium
Az Vesalius
Tongeren, Tongeren, Belgium
CH WAPI Tournai
Tournai, Tournai, Belgium
Sint Augustinus
Wilrijk, Wilrijk, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06.04.INF
Identifier Type: -
Identifier Source: org_study_id