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

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

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.

Study Overview

• Status: Completed
• Conditions: Cow's Milk Protein Allergy
• Intervention / Treatment: Other: Test infant formula with HMOs; Other: Control infant formula without HMOs

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 Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • University Hospital Brussels
  • Brussels, Belgium
    • Cliniques Universitaires Saint Luc
  • Montegnee, Belgium
    • CHC clinique de l'Esperance
• Hungary
  • Budapest, Hungary
    • Clinexpert Gyogycentrum
  • Kecskemét, Hungary
    • Bagoly Egeszseghaz
  • Veszprém, Hungary
    • Csolnoky Ferenc Korhaz
• Italy
  • Ancona, Italy
    • A.O.U Ospedali Riuniti
  • Milano, Italy
    • Ospedale Luigi Sacco, Polo Universitario
  • Naples, Italy
    • University of Naples Federico II
  • Palermo, Italy
    • A.O.U.P - Università degli Studi di Palermo
  • Roma, Italy
    • University of Rome La Sapienza
• Poland
  • Bialystok, Poland
    • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
  • Chorzow, Poland
    • Specjalistyczna Przychodnia Lekarska Medicus
  • Gdansk, Poland
    • Gdańskie Centrum Zdrowia Sp. z o.o.
  • Gostynin, Poland
    • NZOZ Medicus
  • Krakow, Poland
    • Centrum Medyczne Plejady
  • Krakow, Poland
    • ATOPIA - Specjalistyczna Przychodnia Medyczna
  • Rzeszow, Poland
    • Gabinet Lekarski Bartosz Korczowski
  • Tarnow, Poland
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o
  • Zawadzkie, Poland
    • Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.
• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, 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
• Spain
  • Almeria, Spain
    • Hospital de Poniente
  • Barcelona, Spain
    • Eba Centelles
  • Barcelona, Spain
    • Hospital de Nens
  • Barcelona, Spain
    • Hospital QuirónSalud
  • Coruna, Spain
    • Hospital Teresa Herrera
  • Murcia, Spain
    • Hospital Clinico Universitario Virgen de La Arrixaca
• United Kingdom
  • Aylesbury, United Kingdom
    • Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
  • Barnstaple, United Kingdom
    • Northern Devon Healthcare NHS Trust, North Devon District Hospital
  • Burton upon Trent, United Kingdom
    • Burton Hospitals NHS Foundation Trust, Queen's Hospital
  • Carshalton, United Kingdom
    • Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital
  • Exeter, United Kingdom
    • Royal Devon and Exeter NHS Foundation Trust
  • Gillingham, United Kingdom
    • Medway NHS Foundation Trust, Medway Maritime Hospital
  • Great Yarmouth, United Kingdom
    • James Paget University Hospitals NHS Foundation Trust
  • King's Lynn, United Kingdom
    • Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust
  • Leeds, United Kingdom
    • The Leeds Teaching Hospitals Nhs Trust
  • London, United Kingdom
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom
    • Chelsea and Westminster Hospital NHS Foundation Trust
  • Plymouth, United Kingdom
    • Plymouth Hospitals NHS Trust, Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test infant formula with HMOs; Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.	Other: Test infant formula with HMOs; Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
Active Comparator: Control infant formula without HMOs; Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite	Other: Control infant formula without HMOs; Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth expressed as weight gain in grams per day	Body weight measured from enrollment to 4 months of study formula intake	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Growth in terms of body weight.	Body weight (in kilograms) measured from enrollment until infants are 12 months of age.	12 months
Growth in terms of body length	Body length (in centimetres) measured from enrollment until infants are 12 months of age.	12 months
Growth in terms of head circumference	Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.	12 months
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
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
Healthcare resource use assessed with Questionnaire	Questionnaire completed from enrollment until infants are 12 months of age.	12 months

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Chair: Maryam Olesen, Nestlé Health Science Spain

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): August 7, 2018
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 16.08.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No