- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02414243
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy (RAF)
A Multicenter, Randomized, Controlled, Cross-over Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Rome, Italien
- Ospedale Pediatrico Bambino Gesù
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Children with documented cow's milk allergy, confirmed by one of the following criteria, within six months prior to study start (visit 2):
- Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow's milk OR
- Positive open or single-blind oral food challenge with cow's milk carried out under the supervision of a specialist in children with clear immediate reactions and a positive test for specific IgE (in serum [sIgE>0,35 KUI/L] or skin prick test [SPT ≥ 3 mm]) OR
- Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and detectable serum milk-specific IgE or positive skin prick test
- Aged ≤12 years of age at screening.
- Expected consumption of a minimum of 250ml of study formula per day during the open challenge.
- Written informed consent from one or both parents (depending on the local legislation) or legal representative.
Exclusion Criteria:
- Children who receive breastfeeding at study enrolment.
- Had any chronic medical diseases, chromosomal or major congenital anomalies, or major gastrointestinal disease/abnormalities (other the CMPA); had immunodeficiency; antihistamine [excluding eye drops] use in 7 days prior to a food challenge or oral steroid use within 14 days prior to enrolment; unstable asthma; severe uncontrolled eczema;
- Severe anaphylactic reaction [required ≥ 2 doses of epinephrine] to milk or breast milk within the past 2 years;
- Existing illness that could interfere with formula acceptance or identification of allergic reactions.
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: New Amino Acid formula
New Amino-Acid based Infant Formula
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Ordesa's Amino-Acid based Infant Formula
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Aktiv komparator: Control formula
Commercially available Amino Acid Formula
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Commercially available Amino Acid Formula
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula
Tidsramme: 14 days
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To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC).
Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study.
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14 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cow's Milk Allergy Related Symptoms
Tidsramme: 14 days
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Cow's Milk Allergy related Symptoms recorded at visit 1 and visit 4 using the Vandenplas symptom-based score (SBS). The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score ≥ 12, the symptoms are likely cow's milk related. This could potentially be CMPA. If final score <12, the symptoms are less likely related to cow's milk. Look for other causes. |
14 days
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Claudia Banzato, MD, Azienda Ospedaliera Universitaria Integrata, Verona, Italy
- Ledende efterforsker: Maria Pedrosa, MD, Hospital Universitario La Paz
- Ledende efterforsker: Elena Alonso, MD, Hospital General Universitario Gregorio Marañon, Madrid, Spain
- Ledende efterforsker: Montserrat Bosque, MD, Hospital Universitario Parc Taulí Sabadell, Barcelona, Spain
- Ledende efterforsker: Anna Mª Plaza, MD, Hospital Sant Joan de Déu, Barcelona, Spain
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RAF-01-015
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