NCT04893330 (PEPSY) is a clinical trial of pepticate syneo in Milk Hypersensitivity, sponsored by Nutricia Nutrition Clinique.

Who is sponsoring NCT04893330?

NCT04893330 is sponsored by Nutricia Nutrition Clinique.

What drugs are being tested in NCT04893330?

Interventions in NCT04893330: pepticate syneo.

What condition does NCT04893330 study?

NCT04893330 studies Milk Hypersensitivity.

Is NCT04893330 still recruiting?

NCT04893330 is currently completed. Last updated 22 September 2023.

Last reviewed 2023-09-22 · How we verify

NCT04893330: PEPSY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 22 September 2023

What this trial tests

trial testing pepticate syneo in Milk Hypersensitivity in 78 participants. Completed in 30 May 2022.

Timeline

23 June 2021

Primary endpoint
30 May 2022

30 May 2022

Quick facts

Lead sponsor	Nutricia Nutrition Clinique
Status	Completed
Study type	OBSERVATIONAL
Enrollment	78
Start date	23 June 2021
Primary completion	30 May 2022
Estimated completion	30 May 2022
Sites	1 location across France

Drugs / interventions tested

pepticate syneo

Conditions studied

Milk Hypersensitivity — all drugs for Milk Hypersensitivity →

Sponsor

Nutricia Nutrition Clinique

Who can join

8 Months and older, any sex, with Milk Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The Role of Biologics in the Treatment of Food Allergy.
Sindher SB, Fiocchi A, Zuberbier T, Arasi S, et al · · 2024 · cited 21× · PMID 38013157 · DOI 10.1016/j.jaip.2023.11.032
Recovery from symptoms using an extensively hydrolyzed formula with synbiotic in infants with presumed cow's milk allergy.
Lemoine A, Villard-Truc F, Ait Mohamed Amar I, Payot F. · · 2026 · cited 1× · PMID 41347290 · DOI 10.1002/jpn3.70305

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04893330 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nutricia Nutrition Clinique
Last refreshed: 22 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04893330.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing