Cow Milk Protein AllergyPANDANCT07592182
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
A study testing Oral Food Challenge V2, Product administration between V4 and V5 and Oral Food Challenge V3 in people with Cow Milk Protein Allergy and FPIES, run by Lactalis.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 9 months
- Conditions the study is for
- Cow Milk Protein Allergy, FPIES
- What is being tested?
- Oral Food Challenge V2, Product administration between V4 and V5 and Oral Food Challenge V3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3, Product administration between V5 and V6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Food Challenge V2Other
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.
Product administration between V4 and V5Other
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.
Oral Food Challenge V3Other
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.
Product administration between V5 and V6Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Oral Food Challenge V2; Other: Oral Food Challenge 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). Receives: Other: Oral Food Challenge V2; Other: Oral Food Challenge 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). Receives: Other: Product administration between V4 and V5; Other: Product administration between V5 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). Receives: Other: Product administration between V4 and V5; Other: Product administration between V5 and V6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months
Secondary outcomes (5)
Variation of the CoMISS subscores
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.
Measured: 9 months
Variation of the IGSQ score
Variation of the IGSQ score (expressed in a.u., range 13-65) from V4 to V5, and from V5 to V6.
Measured: 9 months
Number of TEAEs
- Total number of TEAEs in the allergy body system
- Total number of TEAEs in the gastrointestinal body system
- Total number of TEAEs
Measured: 9 months
Z-scores for age of anthropometric parameters
Z-scores for age of anthropometric parameters (length (cm), weight (g) and head circumference (cm)) at V4, V5 and V6
Measured: 9 months
Parents' satisfaction
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).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk Protein AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two successive randomised, double-blind, crossovers
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GUERVILLE Mathilde, Study director, LactalisCharlotte MAGNANT, Study director, LactalisAnaïs LEMOINE, Principal investigator, Hôpital Armand Trousseau - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592182
- Sponsor's protocol ID
- 2025-A01706-43
- Acronym
- PANDA
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07592182
- Acronym / sponsor ID
- PANDA / 2025-A01706-43
- Conditions
- Cow Milk Protein Allergy, FPIES
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two successive randomised, double-blind, crossovers
| Arm | Type | Receives |
|---|---|---|
| First cross-over : EHF-STD / AAF | Other | Other: Oral Food Challenge V2, Other: Oral Food Challenge V3At 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). |
| First cross-over : AAF / EHF-AR | Other | Other: Oral Food Challenge V2, Other: Oral Food Challenge V3At 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). |
| Second cross-over : EHF-AR / EHF-STD | Other | Other: Product administration between V4 and V5, Other: Product administration between V5 and V6From 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). |
| Second cross-over : EHF-STD / EHF-AR | Other | Other: Product administration between V4 and V5, Other: Product administration between V5 and V6From 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). |
Who may qualify
- Ages
- 1 month to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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),
- a suspicion of CMPA based on suggestive allergic symptoms
- a confirmed diagnosis of CMPA within the two months before inclusion:
Key exclusion criteria (8 listed)
- 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,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Food Challenge V2At 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 | First cross-over : AAF / EHF-AR, First cross-over : EHF-STD / AAF |
| Product administration between V4 and V5At 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 | Second cross-over : EHF-AR / EHF-STD, Second cross-over : EHF-STD / EHF-AR |
| Oral Food Challenge V3At 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 | First cross-over : AAF / EHF-AR, First cross-over : EHF-STD / AAF |
| Product administration between V5 and V6At 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. | Other | Second cross-over : EHF-AR / EHF-STD, Second cross-over : EHF-STD / EHF-AR |
Primary outcome
The proportion of infants with CMPA who do not experience any allergic symptoms.
Time frame: 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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GUERVILLE Mathilde study director
Lactalis
Charlotte MAGNANT study director
Lactalis
Anaïs LEMOINE principal investigator
Hôpital Armand Trousseau - APHP
Questions about this trial
What is this clinical trial studying?
A study testing Oral Food Challenge V2, Product administration between V4 and V5 and Oral Food Challenge V3 in people with Cow Milk Protein Allergy and FPIES, run by Lactalis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégory ALLAIN (+33 6 65 74 91 49, gregory.allain@biofortis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of infants with CMPA who do not experience any allergic symptoms. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.