Status:
COMPLETED
Interest of Peticate Syneo Infant Formula in Children Allergic to Cow's Milk Protein: Real Life Study
Lead Sponsor:
Nutricia Nutrition Clinique
Conditions:
Milk Hypersensitivity
Eligibility:
All Genders
8+ years
Brief Summary
Nutricia wants to launch a real-life study, to see how the presence of prebiotics and probiotics in the boosted protein hydrolyzate can improve symptoms in the first weeks of use, and supplement the e...
Detailed Description
Nutricia has developed an infant formula intended for children, APLV, from the class of foodstuffs intended for special medical purposes (DADFMS), called Pepticate Syneo. This hypoallergenic formula i...
Eligibility Criteria
Inclusion
- Child aged ≤ 8 months;
- Child newly diagnosed with an allergy to cow's milk proteins (APLV), or with a strong suspicion of APLV (mediated by IgE or not), justifying (according to the doctor) the prescription of Pepticate® Syneo® (extensive hydrolyzate cow's milk protein)
- Child already fed with an infant formula (partially or totally), or whose parents have already made the decision to initiate an infant formula, in addition to or as a follow-up to breastfeeding.
- Authorization of one or more parents or the child's legal representative to collect personal information about the child and the family.
Exclusion
- Child who has already taken an infant formula such as "high protein hydrolyzate" or "amino acid formula";
- Child with a contraindication to taking symbiotics (eg: short bowel syndrome, parenteral nutrition, post-pyloric nutrition, central venous catheter, etc.)
- Child with severe APLV requiring the prescription of an amino acid formula;
- Legal guardian of the protected child (under legal protection, or deprived of liberty by judicial or administrative decision);
- Legal guardian of the child who is not a beneficiary of a social security scheme.
- Inability of the legal representative to understand the study protocol, or doctor's doubts about the ability of the will to comply with the protocol.
Key Trial Info
Start Date :
June 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04893330
Start Date
June 23 2021
End Date
May 30 2022
Last Update
September 22 2023
Active Locations (1)
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1
Cabinet Médical
Charly, France, 69390