Cabinet Médical
Charly, 69390, France
NCT Number: NCT04893330
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 efficacy and safety data of the drug. formula, collected during clinical trials, with real life use. The target population will be children with a definite or suspected diagnosis of APLV, who have never taken a hypoallergenic formula, for whom the doctor decides to prescribe the Pepsicate Syneo formula, regardless of the clinical manifestation of the allergy. These children will be included before the age of 8 months and will be seen again 4 weeks after the prescription. The data from this real-life study will also better characterize the profile of infants taking Pepsicate Syneo. Finally, the perception of the formula by the parents will be collected.
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Notify Me8 month and older
All sexes
Observational
Charly, 69390, France
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 is based on high hydrolyzate of whey protein. It also contains:
In babies with a suspicion of non-IgE-mediated APLV, this symbiotic mixture (IcFOS, scGOS and B. Breve) allowed a modification of the fecal microbiota in 8 weeks, thus approaching the microbiota of breastfed infants of the same age, with an increase in Bifidobacteria and a decrease in Eubacterium rectale / Clostridium coccoides [Fox 2019].
All the available scientific data suggest an excellent tolerance of the Pepticate Syneo formula, and therapeutic efficacy on the manifestations of APLV, whether or not it is mediated by IgE, while ensuring the nutritional needs of children's growth. [Abrahamse-Berkeveld 2016, Giampietro 2001, Vandenplas 1993, Verwimp 1995].
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
follow up of pepticate syneo for one month
Time frame: Day 28
Assessment of the effect of the PEPTICATE SYNEO formula on the evolution of the general condition of a child with a PPLA using a 4-level Likert scale (worse / identical / improved / resolved)
Time frame: Day 28
Evaluation of the effect of the PEPTICATE SYNEO formula on the evolution of allergy symptoms using a 4-level Likert scale (worse / identical / improved / resolved)
Time frame: during one month
Assessment of the effect of the PEPTICATE SYNEO formula on the evolution of allergy symptoms according to the parents using a 4-level Likert scale (worse / identical / improved / resolved)
Time frame: Day 28
Descriptive analysis of the acceptability of PEPTICATE SYNEO by parents using a questionnaire
Time frame: Day 28
The quality of life of the parents (FAQL-PB score) will be measured by a Student test on paired samples.
Time frame: Day 0
Description of the clinical profile of the children at inclusion (Age, anthropometric data; growth; Food history, Risk factors for atopy..).
Time frame: during one month
Evaluation of the infant formula consumption of children before inclusion and during follow-up (lasting 28 days).
Nutricia Nutrition Clinique
Industry
Acronym: PEPSY
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