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

Cow's Milk Protein Allergy Clinical Trial

— CINNAMON  

Official title:

Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085134
• Other study ID #: 16.08.CLI
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: February 8, 2019

Study information

• Verified date: July 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 8, 2019
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Protein Allergy

Intervention

Other:
• Test infant formula with HMOs
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
• Control infant formula without HMOs
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	University Hospital Brussels	Brussels
Belgium	CHC clinique de l'Esperance	Montegnee
Hungary	Clinexpert Gyogycentrum	Budapest
Hungary	Bagoly Egeszseghaz	Kecskemét
Hungary	Csolnoky Ferenc Korhaz	Veszprém
Italy	A.O.U Ospedali Riuniti	Ancona
Italy	Ospedale Luigi Sacco, Polo Universitario	Milano
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
Poland	Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk	Bialystok
Poland	Specjalistyczna Przychodnia Lekarska Medicus	Chorzow
Poland	Gdanskie 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	Rzeszow
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O	Tarnow
Poland	Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.	Zawadzkie
Singapore	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
Spain	Hospital de Poniente	Almeria
Spain	EBA Centelles	Barcelona
Spain	Hospital de Nens	Barcelona
Spain	Hospital Quirónsalud	Barcelona
Spain	Hospital Teresa Herrera	Coruna
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
United Kingdom	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 upon 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	King's 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

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth expressed as weight gain in grams per day	Body weight measured from enrollment to 4 months of study formula intake	4 months
Secondary	Safety and medication use	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.	12 months
Secondary	Growth in terms of body weight.	Body weight (in kilograms) measured from enrollment until infants are 12 months of age.	12 months
Secondary	Growth in terms of body length	Body length (in centimetres) measured from enrollment until infants are 12 months of age.	12 months
Secondary	Growth in terms of head circumference	Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.	12 months
Secondary	Digestive tolerance and alleviation of CMPA	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.	12 months
Secondary	Compliance to study formula intake	Recording daily quantity consumed (in milliliters) in feeding diary for 3 days immediately before each visit from enrollment until last study formula intake.	12 months
Secondary	Healthcare resource use assessed with Questionnaire	Questionnaire completed from enrollment until infants are 12 months of age.	12 months