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

NCT07592182 | Not Yet Recruiting

• 1 other identifier: 2025-A01706-43
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cow Milk Protein Allergy; FPIES

Outcome Measures

Primary Outcomes (1)

• The proportion of infants with CMPA who do not experience any allergic symptoms.

  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

Secondary Outcomes (5)

• Variation of the CoMISS subscores

  9 months

• Variation of the IGSQ score

  9 months

• Number of TEAEs

  9 months

• Z-scores for age of anthropometric parameters

  9 months

• Parents' satisfaction

  9 months

Study Arms (4)

First cross-over : EHF-STD / AAF

OTHER

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).

Other: Oral Food Challenge V2 and V3

First cross-over : AAF / EHF-AR

OTHER

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).

Other: Oral Food Challenge V2 and V3

Second cross-over : EHF-AR / EHF-STD

OTHER

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).

Other: Product administration between V4 and V6

Second cross-over : EHF-STD / EHF-AR

OTHER

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).

Other: Product administration between V4 and V6

Interventions

Oral Food Challenge V2 and V3 OTHER

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. At V3, the second product is administrated (cross-over).

First cross-over : AAF / EHF-AR; First cross-over : EHF-STD / AAF

Product administration between V4 and V6 OTHER

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. At V5, a second allocation is performed and the second product is consumed between V5 and V6 (crossover).

Second cross-over : EHF-AR / EHF-STD; Second cross-over : EHF-STD / EHF-AR

Eligibility Criteria

• Age: 1 Month - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Lactalis: lead

Study Officials

• GUERVILLE Mathilde

  Lactalis

  STUDY DIRECTOR

• Charlotte MAGNANT

  Lactalis

  STUDY DIRECTOR

Central Study Contacts

Grégory ALLAIN

CONTACT

+33 6 65 74 91 49; gregory.allain@biofortis.fr

Basile FRILLEY

CONTACT

+33 6 64 08 92 96; basile.frilley@biofortis.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two successive randomised, double-blind, crossovers

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share