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

NCT ID: NCT03085134

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-02-08

Brief Summary

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.

Detailed Description

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.

Conditions

Cow's Milk Protein Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test infant formula with HMOs

Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.

Group Type: EXPERIMENTAL

Test infant formula with HMOs

Intervention Type: OTHER

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.

Control infant formula without HMOs

Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite

Group Type: ACTIVE_COMPARATOR

Control infant formula without HMOs

Intervention Type: OTHER

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.

Interventions

Test infant formula with HMOs

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.

Intervention Type: OTHER

Control infant formula without HMOs

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.

Intervention Type: OTHER

Eligibility 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.

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Olesen

Role: STUDY_CHAIR

Nestlé Health Science Spain

Locations

Cliniques Universitaires Saint Luc

Brussels, , Belgium

University Hospital Brussels

Brussels, , Belgium

CHC clinique de l'Esperance

Montegnée, , Belgium

Clinexpert Gyogycentrum

Budapest, , Hungary

Bagoly Egeszseghaz

Kecskemét, , Hungary

Csolnoky Ferenc Korhaz

Veszprém, , Hungary

A.O.U Ospedali Riuniti

Ancona, , Italy

Ospedale Luigi Sacco, Polo Universitario

Milan, , Italy

University of Naples Federico II

Naples, , Italy

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

Palermo, , Italy

University of Rome La Sapienza

Roma, , Italy

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

Bialystok, , Poland

Specjalistyczna Przychodnia Lekarska Medicus

Chorzów, , Poland

Gdańskie Centrum Zdrowia Sp. z o.o.

Gdansk, , Poland

NZOZ Medicus

Gostynin, , Poland

ATOPIA - Specjalistyczna Przychodnia Medyczna

Krakow, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

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

Tarnów, , Poland

Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.

Zawadzkie, , Poland

KK Women's and Children's Hospital

Singapore, , Singapore

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

Singapore, , Singapore

Mount Elizabeth Medical Centre - The Child and Allergy Clinic

Singapore, , Singapore

National University Hospital

Singapore, , Singapore

Hospital Teresa Herrera

A Coruña, , Spain

Hospital de Poniente

Almería, , Spain

EBA Centelles

Barcelona, , Spain

Hospital de Nens

Barcelona, , Spain

Hospital Quirónsalud

Barcelona, , Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital

Aylesbury, , United Kingdom

Northern Devon Healthcare NHS Trust, North Devon District Hospital

Barnstaple, , United Kingdom

Burton Hospitals NHS Foundation Trust, Queen's Hospital

Burton-on-Trent, , United Kingdom

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

Carshalton, , United Kingdom

Royal Devon and Exeter NHS Foundation Trust

Exeter, , United Kingdom

Medway NHS Foundation Trust, Medway Maritime Hospital

Gillingham, , United Kingdom

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, , United Kingdom

Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust

Kings Lynn, , United Kingdom

The Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust

London, , United Kingdom

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Plymouth Hospitals NHS Trust, Derriford Hospital

Plymouth, , United Kingdom

Countries

Belgium; Hungary; Italy; Poland; Singapore; Spain; United Kingdom

Other Identifiers

16.08.CLI

Identifier Type: -

Identifier Source: org_study_id