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

Not Applicable

Completed

• Conditions: Cow's Milk Protein Allergy
• Interventions: Other: Control infant formula without HMOs; Other: Test infant formula with HMOs

• Registration Number: NCT03085134
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2017-02-22
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Primary Completion: 2018-08-07
• Study Completion: 2019-02-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control infant formula without HMOs	Control infant formula without HMOs	Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite
Test infant formula with HMOs	Test infant formula with HMOs	Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.

Primary Outcome Measures

Name	Time	Method
Growth expressed as weight gain in grams per day	4 months	Body weight measured from enrollment to 4 months of study formula intake

Secondary Outcome Measures

Name	Time	Method
Safety and medication use	12 months	Assessment of occurrence of adverse events (Number of adverse events per infant and number of infants with adverse events) and use of concomitant medication (specifically amount of antipyretics and antibiotics used per infant and number of infants using these) from enrollment until infants are 12 months of age.
Compliance to study formula intake	12 months	Recording daily quantity consumed (in milliliters) in feeding diary for 3 days immediately before each visit from enrollment until last study formula intake.
Growth in terms of body length	12 months	Body length (in centimetres) measured from enrollment until infants are 12 months of age.
Growth in terms of head circumference	12 months	Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.
Digestive tolerance and alleviation of CMPA	12 months	Recording of stool characteristics and frequency in diary, assessment of infant behavior pattern and medical assessment at each visit from enrollment until last study formula intake. Outcome will be reported as score on CoMiSS tool.
Healthcare resource use assessed with Questionnaire	12 months	Questionnaire completed from enrollment until infants are 12 months of age.
Growth in terms of body weight.	12 months	Body weight (in kilograms) measured from enrollment until infants are 12 months of age.

Trial Locations

Locations (42)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Bagoly Egeszseghaz; 🇭🇺 Kecskemét, Hungary

Ospedale Luigi Sacco, Polo Universitario; 🇮🇹 Milano, Italy

University of Rome La Sapienza; 🇮🇹 Roma, Italy

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

EBA Centelles; 🇪🇸 Barcelona, Spain

Hospital de Poniente; 🇪🇸 Almeria, Spain

Hospital Quirónsalud; 🇪🇸 Barcelona, Spain

Hospital de Nens; 🇪🇸 Barcelona, Spain

Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital; 🇬🇧 Aylesbury, United Kingdom

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Teresa Herrera; 🇪🇸 Coruna, Spain

Northern Devon Healthcare NHS Trust, North Devon District Hospital; 🇬🇧 Barnstaple, United Kingdom

Burton Hospitals NHS Foundation Trust, Queen's Hospital; 🇬🇧 Burton upon Trent, United Kingdom

Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital; 🇬🇧 Carshalton, United Kingdom

Medway NHS Foundation Trust, Medway Maritime Hospital; 🇬🇧 Gillingham, United Kingdom

Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, United Kingdom

James Paget University Hospitals NHS Foundation Trust; 🇬🇧 Great Yarmouth, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust; 🇬🇧 King's Lynn, United Kingdom

The Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Plymouth Hospitals NHS Trust, Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

University Hospital Brussels; 🇧🇪 Brussels, Belgium

CHC clinique de l'Esperance; 🇧🇪 Montegnee, Belgium

Specjalistyczna Przychodnia Lekarska Medicus; 🇵🇱 Chorzow, Poland

Gdańskie Centrum Zdrowia Sp. z o.o.; 🇵🇱 Gdansk, Poland

Clinexpert Gyogycentrum; 🇭🇺 Budapest, Hungary

Csolnoky Ferenc Korhaz; 🇭🇺 Veszprém, Hungary

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk; 🇵🇱 Bialystok, Poland

NZOZ Medicus; 🇵🇱 Gostynin, Poland

ATOPIA - Specjalistyczna Przychodnia Medyczna; 🇵🇱 Krakow, Poland

Centrum Medyczne Plejady; 🇵🇱 Krakow, Poland

Gabinet Lekarski Bartosz Korczowski; 🇵🇱 Rzeszow, Poland

Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.; 🇵🇱 Zawadzkie, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O; 🇵🇱 Tarnow, Poland

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

A.O.U Ospedali Riuniti; 🇮🇹 Ancona, Italy

University of Naples Federico II; 🇮🇹 Naples, Italy

A.O.U.P - Università degli Studi di Palermo; 🇮🇹 Palermo, Italy