Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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].
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pepticate syneo | Dietary Supplement | follow up of pepticate syneo for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| effect on general condition | 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) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on evolution of allergic symptoms | 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) | Day 28 |
| effect on evolution of allergic symptoms according to Parents |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The target population is made up of children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV.
The study plans to include 78 patients.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Médical | Charly | 69390 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
| during one month |
| acceptability | Descriptive analysis of the acceptability of PEPTICATE SYNEO by parents using a questionnaire | Day 28 |
| Parent's quality of life | The quality of life of the parents (FAQL-PB score) will be measured by a Student test on paired samples. | Day 28 |
| CLINICAL PROFILE OF CHILDREN | Description of the clinical profile of the children at inclusion (Age, anthropometric data; growth; Food history, Risk factors for atopy..). | Day 0 |
| Consumption of the formula | Evaluation of the infant formula consumption of children before inclusion and during follow-up (lasting 28 days). | during one month |