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Not yet recruiting NCT07592182

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

No phase Interventional Cow Milk Protein Allergy FPIES

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3, Product administration between V5 and V6.
Who it may be relevant to
Registry conditions: Cow Milk Protein Allergy, FPIES. Basic parameters: 1 months — 9 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other 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.
  • Other 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.
  • Other 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.
  • Other 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.

Primary outcome measures

  • The proportion of infants with CMPA who do not experience any allergic symptoms. [Time frame: 5 months]
Secondary outcome measures (5)
  • Variation of the CoMISS subscores [Time frame: 9 months]
  • Variation of the IGSQ score [Time frame: 9 months]
  • Number of TEAEs [Time frame: 9 months]
  • Z-scores for age of anthropometric parameters [Time frame: 9 months]
  • Parents' satisfaction [Time frame: 9 months]

Eligibility criteria

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:

  • 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
  • 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:

  • GI disease or abnormalities (i.e. short bowel syndrome, chronic intestinal diseases, or GI malformations),
  • Or Other malformations, congenital cardiovascular, kidney, liver, pancreas, metabolic or neurological diseases,
  • Or Immunodeficiency, or chronic infection requiring long-term treatment,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07592182 · 2025-A01706-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗