Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
CINNAMON
1 other identifier
interventional
194
7 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2017
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2019
CompletedJuly 23, 2019
July 1, 2019
1.5 years
February 28, 2017
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Growth expressed as weight gain in grams per day
Body weight measured from enrollment to 4 months of study formula intake
4 months
Secondary Outcomes (7)
Safety and medication use
12 months
Growth in terms of body weight.
12 months
Growth in terms of body length
12 months
Growth in terms of head circumference
12 months
Digestive tolerance and alleviation of CMPA
12 months
- +2 more secondary outcomes
Study Arms (2)
Test infant formula with HMOs
EXPERIMENTALExtensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.
Control infant formula without HMOs
ACTIVE COMPARATORExtensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite
Interventions
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.
Eligibility Criteria
You may qualify if:
- Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- g ≤ birth weight ≤ 4500g
- Written informed consent.
- Infant aged between birth and 6 months.
- Not being breastfed at time of enrollment or mothers of CMPA infant doing breastfeeding and independently elected before enrollment to exclusively formula feed.
- 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.
You may not qualify if:
- Prior treatment with extensively hydrolysed infant formula for more than 72 hours or with amino acid infant formula.
- Congenital illness or malformation that may affect growth.
- Demonstrated chronic malabsorption not due to CMPA.
- Significant pre-natal and/or serious post-natal disease other than CMPA before enrollment (per investigator's medical decision).
- Minor parent(s).
- Infants whose parents or caregivers cannot be expected to comply with study procedures.
- Currently participating or having participated in another clinical trial since birth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maryam Olesen
Nestlé Health Science Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 21, 2017
Study Start
February 22, 2017
Primary Completion
August 7, 2018
Study Completion
February 8, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share