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Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy (PANDA)

21 maja 2026 zaktualizowane przez: Lactalis

Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy: a Clinical Evaluation

This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based formula in infants with cow's milk protein allergy. After a confirmation of the diagnostic, this demonstration will be performed with oral food challenge. Secondarily, a long term tolerance phase will be performed to get growth outcomes with a consumption of the formula compared with a non-enriched formula.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

55

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

I1. Age ≥ 1 month and < 9 months, I2. Exclusively formula fed and planning to be formula-fed for the duration of the study (food diversification allowed),

I3. With:

  1. a suspicion of CMPA based on suggestive allergic symptoms

    • CoMISS score > 10
    • And/or acute allergic symptoms
    • And/or symptoms suggestive of a Food Protein-Induced Enterocolitis Syndrome (FPIES) (major criteria and <3 minor criteria as per consensus guidelines) (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025); OR

  2. a confirmed diagnosis of CMPA within the two months before inclusion:

    • IgE-mediated CMPA (documented history of allergic reaction grade ≤ 3 according to the ordinal food allergy severity score oFASS-5 (Fernández-Rivas et al. 2022) following milk protein ingestion, and sensitization to CMP: blood IgE level specific to cow milk≥ 5 kU/L, or positive skin prick test with papule with fresh cow's milk ≥ 8 mm
    • or non-IgE-mediated CMPA (documented history of eviction/reintroduction test concluding to CMPA),
    • or FPIES (major criteria and ≥3 minor criteria as per consensus guidelines (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025), I4. With a written informed consent signed by the father and mother or legal representative(s), I5. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits, I6. With parents willing to achieve all study interventions, I7. At least one of the legal representatives is affiliated with a social security scheme.

Exclusion Criteria:

E1. Birthweight < 2500 g, E2. Gestational age < 37 weeks, E3. Breastfeeding at the time of inclusion and throughout the study period, E4. Already fed with an AAF, or with the investigational formula EHF-AR, E5. History of anaphylactic reaction grade 4 or 5 according to classification oFASS-5 (Fernández-Rivas et al. 2022), or of severe FPIES (previous reaction with any change in behaviour from baseline, any pallor and dehydration requiring intravenous fluids), after mammalian milk exposure, E6. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections,

E7. History / diagnosis of:

  1. GI disease or abnormalities (i.e. short bowel syndrome, chronic intestinal diseases, or GI malformations),
  2. Or Other malformations, congenital cardiovascular, kidney, liver, pancreas, metabolic or neurological diseases,
  3. Or Immunodeficiency, or chronic infection requiring long-term treatment,
  4. Or Genetic diseases and chromosomal abnormalities, E8. Suspected or confirmed food allergies or intolerances, other than CMPA, E9. Currently enrolled in another clinical study, or in exclusion period from a previous clinical study, E10. Whose legal representatives have psychological or linguistic incapability to sign the informed consent, E11. Impossibility to contact the legal representatives in case of emergency.

After V1, the participant will be excluded from participation in this trial if he/she fulfils the following criteria:

E12. No allergic symptoms following the OFC with a standard CMPF.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: First cross-over : EHF-STD / AAF

At V2 visit, an OFC is performed with EHF-STD (extensively hydrolysed anti-regurgitation casein-based formula).

At V3 visit, an OFC is performed with AAF (amino acid formula).
Inny: Oral Food Challenge V2

At V2, a randomization is performed and a product is allocated to be administrated in an OFC. According to the randomization the product is EHF-AR or AAF.

The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear.

If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated.

Inny: Oral Food Challenge V3

At V3, the second product is administrated (EHF-AR or AAF)(cross-over). The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear.

If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated.
Inny: First cross-over : AAF / EHF-AR
At V2 visit, an OFC is performed with AAF (amino acid formula). At V3 visit, an OFC is performed with EHF-STD (extensively hydrolysed anti-regurgitation casein-based formula).
Inny: Oral Food Challenge V2

At V2, a randomization is performed and a product is allocated to be administrated in an OFC. According to the randomization the product is EHF-AR or AAF.

The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear.

If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated.

Inny: Oral Food Challenge V3

At V3, the second product is administrated (EHF-AR or AAF)(cross-over). The progressive doses of 2, 5, 10, 25, 50, and 100 mL are administered to the patient at 15-minute intervals as long as no symptoms appear.

If no symptoms appear within 3 hours after administration of the last dose, the product is considered to be tolerated.
Inny: Second cross-over : EHF-AR / EHF-STD

From V4 to V5 visit, the subject consumes EHF-AR (extensively hydrolysed anti-regurgitation casein-based formula).

From V5 to V6 visit, the subject consumes EHF-STD (extensively hydrolysed casein-based formula).
Inny: Product administration between V4 and V5

At V4, a randomization is performed and a product is allocated for the consumption between V4 and V5. According to the randomization, the product is EHF-AR or EHF-STD.

The patient will be fed this product for 2 months.

Inny: Product administration between V5 and V6

At V5, a second allocation is performed and the second product is consumed between V5 and V6 (EHF-AR or EHF-STD)(crossover).

The patient will be fed this product for 2 months.
Inny: Second cross-over : EHF-STD / EHF-AR

From V4 to V5 visit, the subject consumes EHF-STD (extensively hydrolysed casein-based formula).

From V5 to V6 visit, the subject consumes EHF-AR (extensively hydrolysed anti-regurgitation casein-based formula).
Inny: Product administration between V4 and V5

At V4, a randomization is performed and a product is allocated for the consumption between V4 and V5. According to the randomization, the product is EHF-AR or EHF-STD.

The patient will be fed this product for 2 months.

Inny: Product administration between V5 and V6

At V5, a second allocation is performed and the second product is consumed between V5 and V6 (EHF-AR or EHF-STD)(crossover).

The patient will be fed this product for 2 months.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The proportion of infants with CMPA who do not experience any allergic symptoms.
Ramy czasowe: 5 months
The proportion of infants with CMPA who do not experience any allergic symptoms that lead to study discontinuation, as per the investigator, during the first week following the OFC with the EHF-AR formula, including the OFC period itself (between V2 and V3, or V3 and V4).
5 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Variation of the CoMISS subscores
Ramy czasowe: 9 months

Variation of the CoMISS subscores (crying, regurgitation, stools, respiratory symptoms, and skin signs) (expressed in arbitrary unit (a.u.), range 0-33) between:

  • V4 and PC2
  • V5 and PC3
  • V4 and V5,
  • V5 and V6.
9 months
Variation of the IGSQ score
Ramy czasowe: 9 months
Variation of the IGSQ score (expressed in a.u., range 13-65) from V4 to V5, and from V5 to V6.
9 months
Number of TEAEs
Ramy czasowe: 9 months
  • Total number of TEAEs in the allergy body system
  • Total number of TEAEs in the gastrointestinal body system
  • Total number of TEAEs
9 months
Z-scores for age of anthropometric parameters
Ramy czasowe: 9 months
Z-scores for age of anthropometric parameters (length (cm), weight (g) and head circumference (cm)) at V4, V5 and V6
9 months
Parents' satisfaction
Ramy czasowe: 9 months

Rate of parents' answer to the following questions:

  • "Did your baby accept the formula well?" at PC2 and PC3 (yes / somewhat / no),
  • "Did the formula reduce your baby's spit-up symptoms?" at PC2 and PC3 (yes / somewhat / no / not applicable (no symptoms)),
  • "Are you generally satisfied with the formula?" at V5 and V6 (yes / somewhat / no),
  • "Would you recommend this formula to other parents?" at V5 and at V6 (yes / no / no opinion).
9 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lactalis

Śledczy

  • Dyrektor Studium: GUERVILLE Mathilde, Lactalis
  • Dyrektor Studium: Charlotte MAGNANT, Lactalis
  • Główny śledczy: Anaïs LEMOINE, Hôpital Armand Trousseau - APHP

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 marca 2028

Ukończenie studiów (Szacowany)

1 lipca 2028

Daty rejestracji na studia

Pierwszy przesłany

5 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

18 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2025-A01706-43

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na FPIES

Badania kliniczne na Oral Food Challenge V2

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