Interest of Peticate Syneo Infant Formula in Children Allergic to Cow's Milk Protein: Real Life Study

NCT04893330 | Completed

• 1 other identifier: 2021- A00703-38
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Milk Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Effect on evolution of allergic symptoms

  Day 28

• effect on evolution of allergic symptoms according to Parents

  during one month

• acceptability

  Day 28

• Parent's quality of life

  Day 28

• CLINICAL PROFILE OF CHILDREN

  Day 0

Study Arms (1)

patients

children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV

Dietary Supplement: pepticate syneo

Interventions

pepticate syneo DIETARY_SUPPLEMENT

follow up of pepticate syneo for one month

patients

Eligibility Criteria

• Age: 8 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Nutrition Clinique: lead

Study Sites (1)

Cabinet Médical

Charly, 69390, France

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 19, 2021
• Study Start: June 23, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 22, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)