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

Primary Purpose

Cow's Milk Protein Allergy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Test infant formula with HMOs
Control infant formula without HMOs
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow's Milk Protein Allergy

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaires Saint Luc
  • University Hospital Brussels
  • CHC clinique de l'Esperance
  • Clinexpert Gyogycentrum
  • Bagoly Egeszseghaz
  • Csolnoky Ferenc Korhaz
  • A.O.U Ospedali Riuniti
  • Ospedale Luigi Sacco, Polo Universitario
  • University of Naples Federico II
  • A.O.U.P - Università degli Studi di Palermo
  • University of Rome La Sapienza
  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
  • Specjalistyczna Przychodnia Lekarska Medicus
  • Gdańskie Centrum Zdrowia Sp. z o.o.
  • NZOZ Medicus
  • ATOPIA - Specjalistyczna Przychodnia Medyczna
  • Centrum Medyczne Plejady
  • Gabinet Lekarski Bartosz Korczowski
  • Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O
  • Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.
  • KK Women's and Children's Hospital
  • Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic
  • Mount Elizabeth Medical Centre - The Child and Allergy Clinic
  • National University Hospital
  • Hospital de Poniente
  • EBA Centelles
  • Hospital de Nens
  • Hospital Quirónsalud
  • Hospital Teresa Herrera
  • Hospital Clínico Universitario Virgen de la Arrixaca
  • Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
  • Northern Devon Healthcare NHS Trust, North Devon District Hospital
  • Burton Hospitals NHS Foundation Trust, Queen's Hospital
  • Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital
  • Royal Devon and Exeter NHS Foundation Trust
  • Medway NHS Foundation Trust, Medway Maritime Hospital
  • James Paget University Hospitals NHS Foundation Trust
  • Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust
  • The Leeds Teaching Hospitals NHS Trust
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • Plymouth Hospitals NHS Trust, Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test infant formula with HMOs

Control infant formula without HMOs

Arm Description

Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.

Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2017
Last Updated
July 22, 2019
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT03085134
Brief Title
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
Acronym
CINNAMON
Official Title
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
August 7, 2018 (Actual)
Study Completion Date
February 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Protein Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test infant formula with HMOs
Arm Type
Experimental
Arm Description
Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.
Arm Title
Control infant formula without HMOs
Arm Type
Active Comparator
Arm Description
Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite
Intervention Type
Other
Intervention Name(s)
Test infant formula with HMOs
Intervention Description
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
Intervention Type
Other
Intervention Name(s)
Control infant formula without HMOs
Intervention Description
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.
Primary Outcome Measure Information:
Title
Growth expressed as weight gain in grams per day
Description
Body weight measured from enrollment to 4 months of study formula intake
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Safety and medication use
Description
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.
Time Frame
12 months
Title
Growth in terms of body weight.
Description
Body weight (in kilograms) measured from enrollment until infants are 12 months of age.
Time Frame
12 months
Title
Growth in terms of body length
Description
Body length (in centimetres) measured from enrollment until infants are 12 months of age.
Time Frame
12 months
Title
Growth in terms of head circumference
Description
Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.
Time Frame
12 months
Title
Digestive tolerance and alleviation of CMPA
Description
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.
Time Frame
12 months
Title
Compliance to study formula intake
Description
Recording daily quantity consumed (in milliliters) in feeding diary for 3 days immediately before each visit from enrollment until last study formula intake.
Time Frame
12 months
Title
Healthcare resource use assessed with Questionnaire
Description
Questionnaire completed from enrollment until infants are 12 months of age.
Time Frame
12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2500g ≤ 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Olesen
Organizational Affiliation
Nestlé Health Science Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
Country
Belgium
Facility Name
CHC clinique de l'Esperance
City
Montegnee
Country
Belgium
Facility Name
Clinexpert Gyogycentrum
City
Budapest
Country
Hungary
Facility Name
Bagoly Egeszseghaz
City
Kecskemét
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprém
Country
Hungary
Facility Name
A.O.U Ospedali Riuniti
City
Ancona
Country
Italy
Facility Name
Ospedale Luigi Sacco, Polo Universitario
City
Milano
Country
Italy
Facility Name
University of Naples Federico II
City
Naples
Country
Italy
Facility Name
A.O.U.P - Università degli Studi di Palermo
City
Palermo
Country
Italy
Facility Name
University of Rome La Sapienza
City
Roma
Country
Italy
Facility Name
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
City
Bialystok
Country
Poland
Facility Name
Specjalistyczna Przychodnia Lekarska Medicus
City
Chorzow
Country
Poland
Facility Name
Gdańskie Centrum Zdrowia Sp. z o.o.
City
Gdansk
Country
Poland
Facility Name
NZOZ Medicus
City
Gostynin
Country
Poland
Facility Name
ATOPIA - Specjalistyczna Przychodnia Medyczna
City
Krakow
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszow
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O
City
Tarnow
Country
Poland
Facility Name
Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.
City
Zawadzkie
Country
Poland
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore
Facility Name
Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic
City
Singapore
Country
Singapore
Facility Name
Mount Elizabeth Medical Centre - The Child and Allergy Clinic
City
Singapore
Country
Singapore
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Hospital de Poniente
City
Almeria
Country
Spain
Facility Name
EBA Centelles
City
Barcelona
Country
Spain
Facility Name
Hospital de Nens
City
Barcelona
Country
Spain
Facility Name
Hospital Quirónsalud
City
Barcelona
Country
Spain
Facility Name
Hospital Teresa Herrera
City
Coruna
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
City
Aylesbury
Country
United Kingdom
Facility Name
Northern Devon Healthcare NHS Trust, North Devon District Hospital
City
Barnstaple
Country
United Kingdom
Facility Name
Burton Hospitals NHS Foundation Trust, Queen's Hospital
City
Burton upon Trent
Country
United Kingdom
Facility Name
Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital
City
Carshalton
Country
United Kingdom
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
Country
United Kingdom
Facility Name
Medway NHS Foundation Trust, Medway Maritime Hospital
City
Gillingham
Country
United Kingdom
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust
City
King's Lynn
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust, Derriford Hospital
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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