Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy
5. juli 2012 opdateret af: Roberto Berni Canani, Federico II University
Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated.
Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition.
Main demographic and clinical characteristics were collected for each patient.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
300
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 1 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
We prospectively evaluated otherwise healthy infants (1-12 months of age at the diagnosis) visit one the Pediatric Gastroenterology and Allergology Centre because of the necessity of a diagnostic oral food challenge for cow's milk proteins.
Children were in stable clinical condition without signs of CMA already on exclusion diet with an hypoallergenic formula for a period of 7-15 days as presented by the general paediatrician, immediately the symptoms appear and before being attended at the Center for diagnosis of CMA.
Beskrivelse
Inclusion Criteria:
- Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated
Exclusion Criteria:
- Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
infants receiving extensively hydrolysed casein formula
infants receiving extensively hydrolysed casein formula as substitutive formula
|
|
extensively hydrolysed casein formula with Lactobacillus GG
infants receiving extensively hydrolysed casein with LGG as substitutive formula
|
|
infants receiving rice hydrolyzed formula
infants receiving rice hydrolyzed formula as substitutive formula
|
|
infants receiving soy-based formula
infants receiving soy-based formula as substitutive formula
|
|
infants receiving amino-acid based formula
infants receiving amino-acid based formula as substitutive formula
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy
Tidsramme: about 4 year
|
. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated.
Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.
A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition.
Main demographic and clinical characteristics were collected for each patient.
|
about 4 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2008
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
3. juli 2012
Først indsendt, der opfyldte QC-kriterier
5. juli 2012
Først opslået (Skøn)
6. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 013908
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Komælksallergi
-
USDA, Western Human Nutrition Research CenterUniversity of Copenhagen; Bill and Melinda Gates Foundation; International... og andre samarbejdspartnereRekrutteringHuman Milk Nutrient Reference VærdierDanmark, Bangladesh, Brasilien, Gambia
-
Nutricia ResearchAktiv, ikke rekrutterendeVækst | Tolerance | Sikkerhed | Emner, der har brug for en Human Milk Fortifier (HMF)Holland, Frankrig, Tyskland, Det Forenede Kongerige