Clinical trial NCT03085134: Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
Official title: Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow's Milk Protein Allergy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 194
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Growth expressed as weight gain in grams per day
timeFrame: 4 months
Secondary outcomes:
measure: Safety and medication use
timeFrame: 12 months
measure: Growth in terms of body weight.
timeFrame: 12 months
measure: Growth in terms of body length
timeFrame: 12 months
measure: Growth in terms of head circumference
timeFrame: 12 months
measure: Digestive tolerance and alleviation of CMPA
timeFrame: 12 months
measure: Compliance to study formula intake
timeFrame: 12 months
measure: Healthcare resource use assessed with Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Montegnee
country: Belgium
facility: CHC clinique de l'Esperance
city: Budapest
country: Hungary
facility: Clinexpert Gyogycentrum
city: Kecskemét
country: Hungary
facility: Bagoly Egeszseghaz
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Ancona
country: Italy
facility: A.O.U Ospedali Riuniti
city: Milano
country: Italy
facility: Ospedale Luigi Sacco, Polo Universitario
city: Naples
country: Italy
facility: University of Naples Federico II
city: Palermo
country: Italy
facility: A.O.U.P - Università degli Studi di Palermo
city: Roma
country: Italy
facility: University of Rome La Sapienza
city: Bialystok
country: Poland
facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
city: Chorzow
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Medicus
city: Gdansk
country: Poland
facility: Gdańskie Centrum Zdrowia Sp. z o.o.
city: Gostynin
country: Poland
facility: NZOZ Medicus
city: Krakow
country: Poland
facility: ATOPIA - Specjalistyczna Przychodnia Medyczna
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Rzeszow
country: Poland
facility: Gabinet Lekarski Bartosz Korczowski
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O
city: Zawadzkie
country: Poland
facility: Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic
city: Singapore
country: Singapore
facility: Mount Elizabeth Medical Centre - The Child and Allergy Clinic
city: Singapore
country: Singapore
facility: National University Hospital
city: Almeria
country: Spain
facility: Hospital de Poniente
city: Barcelona
country: Spain
facility: EBA Centelles
city: Barcelona
country: Spain
facility: Hospital de Nens
city: Barcelona
country: Spain
facility: Hospital Quirónsalud
city: Coruna
country: Spain
facility: Hospital Teresa Herrera
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
city: Barnstaple
country: United Kingdom
facility: Northern Devon Healthcare NHS Trust, North Devon District Hospital
city: Burton upon Trent
country: United Kingdom
facility: Burton Hospitals NHS Foundation Trust, Queen's Hospital
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust, Medway Maritime Hospital
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust, Derriford Hospital
Study officials:
affiliation: Nestlé Health Science Spain
name: Maryam Olesen
role: STUDY_CHAIR
References: