FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides

Study Purpose

The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a growth in line with infants fed with a comparable FSMP formula but without HMOs (control formula). The secondary objectives are to assess whether consumption of Test formula by CMPA infants (i) reduces medication use and risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well tolerated and allows for age appropriate growth and (iii) reduces health care costs.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages N/A - 6 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2. 2500g ≤ birth weight ≤ 4500g 3. Written informed consent. 4. Infant aged between birth and 6 months. 5. Not being breastfed at time of enrollment or mothers of CMPA infant doing breastfeeding and independently elected before enrollment to exclusively formula feed. 6. Infants with physician diagnosed (and untreated with extensively hydrolysed or amino acid infant formula) Cow Milk Protein Allergy as per standard clinical practice and with at least 2 protocol specified symptoms present.

Exclusion Criteria:

1. Prior treatment with extensively hydrolysed infant formula for more than 72 hours or with amino acid infant formula. 2. Congenital illness or malformation that may affect growth. 3. Demonstrated chronic malabsorption not due to CMPA. 4. Significant pre-natal and/or serious post-natal disease other than CMPA before enrollment (per investigator's medical decision). 5. Minor parent(s). 6. Infants whose parents or caregivers cannot be expected to comply with study procedures. 7. Currently participating or having participated in another clinical trial since birth.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03085134

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Nestlé

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Maryam Olesen
Principal Investigator Affiliation Nestlé Health Science Spain

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Belgium, Hungary, Italy, Poland, Singapore, Spain, United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cow's Milk Protein Allergy
Additional Details

Infants with physician diagnosed CMPA, aged between birth and 6 months of age will take either the control or new test infant formula for 4 months and if judged suitable by physician, up to maximum of 12 months of age. Growth, adverse events, medication use and tolerance to formula will be assessed. As part of exploratory objectives, the study will also explore possible mode of action of the Test formula in CMPA infants, by assessing whether consumption of Test formula by CMPA infants affects stool microbiota and metabolic signatures as well as urine metabolic signatures and whether such changes can be associated to the intestinal inflammatory/health status, and the clinical measures.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cliniques Universitaires Saint Luc, Brussels, Belgium

Status

Not yet recruiting

Address

Cliniques Universitaires Saint Luc

Brussels, ,

Site Contact

Francoise Smets

(65) 6635 2209

University Hospital Brussels, Brussels, Belgium

Status

Recruiting

Address

University Hospital Brussels

Brussels, ,

Site Contact

Yvan VandenPlas

(65) 6635 2209

CHC clinique de l'Esperance, Montegnee, Belgium

Status

Recruiting

Address

CHC clinique de l'Esperance

Montegnee, ,

Site Contact

Stephanie Colinet

(65) 6635 2209

Clinexpert Gyogycentrum, Budapest, Hungary

Status

Recruiting

Address

Clinexpert Gyogycentrum

Budapest, ,

Site Contact

Zsuzsanna Tengelyi

(65) 6635 2209

Bagoly Egeszseghaz, Kecskemét, Hungary

Status

Recruiting

Address

Bagoly Egeszseghaz

Kecskemét, ,

Site Contact

Julia Komlodi

(65) 6635 2209

Csolnoky Ferenc Korhaz, Veszprém, Hungary

Status

Not yet recruiting

Address

Csolnoky Ferenc Korhaz

Veszprém, ,

Site Contact

Eva Szabo

(65) 6635 2209

A.O.U Ospedali Riuniti, Ancona, Italy

Status

Recruiting

Address

A.O.U Ospedali Riuniti

Ancona, ,

Site Contact

Carlo Catassi

(65) 6635 2209

Ospedale Luigi Sacco, Polo Universitario, Milano, Italy

Status

Recruiting

Address

Ospedale Luigi Sacco, Polo Universitario

Milano, ,

Site Contact

Gian Vincenzo Zuccotti

(65) 6635 2209

University of Naples Federico II, Naples, Italy

Status

Recruiting

Address

University of Naples Federico II

Naples, ,

Site Contact

Roberto Berni Canani

(65) 6635 2209

Palermo, Italy

Status

Not yet recruiting

Address

A.O.U.P - Università degli Studi di Palermo

Palermo, ,

Site Contact

Salvatore Accomando

(65) 6635 2209

University of Rome La Sapienza, Roma, Italy

Status

Recruiting

Address

University of Rome La Sapienza

Roma, ,

Site Contact

Salvatore Cucchiara

(65) 6635 2209

Bialystok, Poland

Status

Active, not recruiting

Address

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

Bialystok, ,

Site Contact

(65) 6635 2209

Chorzow, Poland

Status

Active, not recruiting

Address

Specjalistyczna Przychodnia Lekarska Medicus

Chorzow, ,

Site Contact

(65) 6635 2209

Gdańskie Centrum Zdrowia Sp. z o.o., Gdansk, Poland

Status

Active, not recruiting

Address

Gdańskie Centrum Zdrowia Sp. z o.o.

Gdansk, ,

Site Contact

(65) 6635 2209

NZOZ Medicus, Gostynin, Poland

Status

Active, not recruiting

Address

NZOZ Medicus

Gostynin, ,

Site Contact

(65) 6635 2209

Krakow, Poland

Status

Active, not recruiting

Address

ATOPIA - Specjalistyczna Przychodnia Medyczna

Krakow, ,

Site Contact

(65) 6635 2209

Centrum Medyczne Plejady, Krakow, Poland

Status

Active, not recruiting

Address

Centrum Medyczne Plejady

Krakow, ,

Site Contact

(65) 6635 2209

Gabinet Lekarski Bartosz Korczowski, Rzeszow, Poland

Status

Active, not recruiting

Address

Gabinet Lekarski Bartosz Korczowski

Rzeszow, ,

Site Contact

(65) 6635 2209

Tarnow, Poland

Status

Active, not recruiting

Address

Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O

Tarnow, ,

Site Contact

(65) 6635 2209

Zawadzkie, Poland

Status

Active, not recruiting

Address

Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.

Zawadzkie, ,

Site Contact

(65) 6635 2209

KK Women's and Children's Hospital, Singapore, Singapore

Status

Recruiting

Address

KK Women's and Children's Hospital

Singapore, ,

Site Contact

Anne Goh

(65) 6635 2209

Singapore, Singapore

Status

Recruiting

Address

Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic

Singapore, ,

Site Contact

Wen Chin Chiang

(65) 6635 2209

Singapore, Singapore

Status

Recruiting

Address

Mount Elizabeth Medical Centre - The Child and Allergy Clinic

Singapore, ,

Site Contact

Bee Wah Lee

(65) 6635 2209

National University Hospital, Singapore, Singapore

Status

Not yet recruiting

Address

National University Hospital

Singapore, ,

Site Contact

Alison Joanne Lee

(65) 6635 2209

Hospital de Poniente, Almeria, Spain

Status

Not yet recruiting

Address

Hospital de Poniente

Almeria, ,

Site Contact

Francisco Canabate

(65) 6635 2209

EBA Centelles, Barcelona, Spain

Status

Recruiting

Address

EBA Centelles

Barcelona, ,

Site Contact

Angels Ulied Arminana

(65) 6635 2209

Hospital de Nens, Barcelona, Spain

Status

Recruiting

Address

Hospital de Nens

Barcelona, ,

Site Contact

Alfonso Malet

(65) 6635 2209

Hospital Quirónsalud, Barcelona, Spain

Status

Recruiting

Address

Hospital Quirónsalud

Barcelona, ,

Site Contact

Rocio Porcel Rubio

(65) 6635 2209

Hospital Teresa Herrera, Coruna, Spain

Status

Recruiting

Address

Hospital Teresa Herrera

Coruna, ,

Site Contact

Ana Moreno Alvarez

(65) 6635 2209

Murcia, Spain

Status

Recruiting

Address

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, ,

Site Contact

Jose Manuel Lucas Moreno

(65) 6635 2209

Aylesbury, United Kingdom

Status

Recruiting

Address

Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital

Aylesbury, ,

Site Contact

Prakash Dey

(65) 6635 2209

Barnstaple, United Kingdom

Status

Recruiting

Address

Northern Devon Healthcare NHS Trust, North Devon District Hospital

Barnstaple, ,

Site Contact

Halima Sadiya Gumi

(65) 6635 2209

Burton upon Trent, United Kingdom

Status

Recruiting

Address

Burton Hospitals NHS Foundation Trust, Queen's Hospital

Burton upon Trent, ,

Site Contact

Mansoor Ahmed

(65) 6635 2209

Carshalton, United Kingdom

Status

Not yet recruiting

Address

Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital

Carshalton, ,

Site Contact

Ralf Hartung

(65) 6635 2209

Dartford, United Kingdom

Status

Withdrawn

Address

Dartford And Gravesham NHS Trust, Darent Valley Hospital

Dartford, ,

Site Contact

(65) 6635 2209

Exeter, United Kingdom

Status

Recruiting

Address

Royal Devon and Exeter NHS Foundation Trust

Exeter, ,

Site Contact

Sian Ludman

(65) 6635 2209

Gillingham, United Kingdom

Status

Not yet recruiting

Address

Medway NHS Foundation Trust, Medway Maritime Hospital

Gillingham, ,

Site Contact

Bhavdeep Jani

(65) 6635 2209

Great Yarmouth, United Kingdom

Status

Recruiting

Address

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, ,

Site Contact

John Chapman

(65) 6635 2209

King's Lynn, United Kingdom

Status

Recruiting

Address

Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust

King's Lynn, ,

Site Contact

Huda Fawi

(65) 6635 2209

The Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Status

Not yet recruiting

Address

The Leeds Teaching Hospitals NHS Trust

Leeds, ,

Site Contact

Donald Hodge

(65) 6635 2209

London, United Kingdom

Status

Not yet recruiting

Address

Chelsea and Westminster Hospital NHS Foundation Trust

London, ,

Site Contact

John Fell

(65) 6635 2209

London, United Kingdom

Status

Not yet recruiting

Address

King's College Hospital NHS Foundation Trust

London, ,

Site Contact

Babu Vadamalayan

(65) 6635 2209

Plymouth, United Kingdom

Status

Recruiting

Address

Plymouth Hospitals NHS Trust, Derriford Hospital

Plymouth, ,

Site Contact

Denise Ullmann

(65) 6635 2209

Stoke, United Kingdom

Status

Withdrawn

Address

University Hospitals Of North Midlands NHS Trust, Royal Stoke University Hospital and County Hospital

Stoke, ,

Site Contact

(65) 6635 2209

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.