Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04893330 |
| Other study ID # |
2021- A00703-38 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 23, 2021 |
| Est. completion date |
May 30, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Nutricia Nutrition Clinique |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 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.
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 is based on high hydrolyzate of whey protein. It also contains:
- IcFOS and scGOS prebiotic fibers. These oligosaccharides are well tolerated and promote
the induction of a favorable gut microbiota and an improvement in faecal characteristics
[Arslanoglu 2008, Moro 2006].
- The probiotic strain Bifidobaterium Breve M-16V. B. breve is the most common species of
bifidobacteria in human milk [Martin 2009]. The B. breve M16-V strain, isolated from the
stool of a healthy infant, is approved in food by health authorities and conforms to the
recommendations of the American Academy of Pediatrics [2000]. It helps promote the
implantation of beneficial bacteria in the intestinal microbiota of young children
[Akiyama 1994, Taniuchi 2005, van der Aa 2010]. Preclinical data suggest that it reduces
the allergic immune response [Hougee 2010, Inoue 2009]. In clinical studies, it helps
reduce atopic dermatitis in children with APLV [Hattori 2003, Taniuchi 2005]. In
addition, the prebiotic / probiotic combination (also called symbiotic) shows a
synergistic effect in mice in reducing allergic manifestations [Schouten 2009]. Used in
children born by cesarean section, it helps restore intestinal colonization by
bifidobacteria, to a level similar to that of infants born vaginally and breastfed [Chua
2017].
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].
