A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy

PHASE3CompletedINTERVENTIONAL
Enrollment

855

Participants

Timeline

Start Date

March 30, 2017

Primary Completion Date

March 25, 2020

Study Completion Date

March 25, 2020

Conditions
Immunity
Interventions
OTHER

Infant formula with added synbiotics

Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.

OTHER

Standard infant formula

Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).

Trial Locations (59)

Unknown

Algemeen Stedelijk Ziekenhuis, Aalst

Cliniques universitaires Saint-Luc, Brussels

Universitair Ziekenhuis Brussel, Brussels

Centre Hospitalier Régional de Namur, Namur

MUDr. Daniel Drazan, prakticky lekar pro deti a dorost, Prague

MUDr. Jitka Fabianova, Prague

Prakticky lekar pro deti a dorost, Prague

Ustav pro peci o matku a dite, Prague

Nemocnice Strakonice, a.s., Strakonice

Charité Universitätsmedizin Berlin, Berlin

Queen Mary Hospital, Hong Kong

Prince of Wales Hospital, Shatin

Dr. Kenessey Albert Korhaz-Rendelointezet, Balassagyarmat

Pestszentimrei Gyermekrendelő / Elitance Duo Kft., Budapest

Rózsavölgyi Gyermekháziorvosi Rendelő / CEBA Egészségügyi Bt., Budapest

Gyermekorvosi Rendelő, Debrecen

Futurenest Kft., Miskolc

Prehospital Med Kft, Miskolc

Kanizsai Dorottya Korhaz, Nagykanizsa

Házi Gyermekorvosi Rendelő /Babadoki Kft., Szeged

Hillel Yaffe Medical center, Hadera

Rambam Health Care Campus, Haifa

Meir Medical Center, Kfar Saba

Schneider Children's Medical, Petah Tikva

Kaplan Medical Center, Rehovot

Tel Aviv Sourasky Medical Center, Tel Aviv

Ospdale Maggiore Policlinico, Fondazione IRCCS Ca' Granda, Milan

IRCCS Policlinico San Matteo, Università degli studi di Pavi, Pavia

UOC Allergologia, Osp. Pediatrico Bambino Gesù, IRCCS;, Roma

VU University Medical Center, Amsterdam

PT&R, Beek

Deventer Ziekenhuis, Deventer

EB UtrechtResearch BV, Utrecht

Kandang Kerbau Women's and Children's Hospital, Singapore

National University Hospital, Singapore

PEGYS s.r.o., Dolný Kubín

Juvenalia, s.r.o., Dunajská Streda

GASTREN, spol. s.r.o., Košice

PEDMAN s.r.o., Martin

Univerzitna nemocnica Martin, Martin

Fakultna nemocnica Nitra, Nitra

GASTOL s.r.o., Prešov

Fakultna nemocnica Trencin, Trenčín

Ambulancia vseobecneho lekara pre deti a dorast, Zlaté Moravce

Hospital HLA Inmaculada Servicio de Pediatría, Granada

Hospital Universitario Virgen de las Nieves, Granada

Hospital Materno Infantil La Paz, Madrid

Hospital Sant Joan de Deu, Manresa

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

Instituto Hispalense de Pediatría, Seville

Hospital Universitari i Politecnic La Fe, Valencia

China Medical University Hospital, Taichung

LinKou Chang Gung Memorial Hospital, Taoyuan District

Royal London Hospital, London

University College Hospital, London

Central Manchester University Hospitals NHS Foundation Trust, Manchester

The Newcastle Hospitals NHS Foundation Trust, Newcastle

University Hospital Southampton NHS Foundation Trust, Southampton

4819 EV

Amphia Ziekenhuis, Breda

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nutricia Research

INDUSTRY