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

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT03085134

Collaborator

(none)

194

Enrollment

Locations

Arms

23.5

Actual Duration (Months)

4.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cow's Milk Protein Allergy	Other: Test infant formula with HMOs Other: Control infant formula without HMOs	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2017

Actual Primary Completion Date :

Aug 7, 2018

Actual Study Completion Date :

Feb 8, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and medication use [12 months]
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. [12 months]
Body weight (in kilograms) measured from enrollment until infants are 12 months of age.
Growth in terms of body length [12 months]
Body length (in centimetres) measured from enrollment until infants are 12 months of age.
Growth in terms of head circumference [12 months]
Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.
Digestive tolerance and alleviation of CMPA [12 months]
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 [12 months]
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 [12 months]
Questionnaire completed from enrollment until infants are 12 months of age.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Cliniques Universitaires Saint Luc	Brussels	Belgium
2	University Hospital Brussels	Brussels	Belgium
3	CHC clinique de l'Esperance	Montegnee	Belgium
4	Clinexpert Gyogycentrum	Budapest	Hungary
5	Bagoly Egeszseghaz	Kecskemét	Hungary
6	Csolnoky Ferenc Korhaz	Veszprém	Hungary
7	A.O.U Ospedali Riuniti	Ancona	Italy
8	Ospedale Luigi Sacco, Polo Universitario	Milano	Italy
9	University of Naples Federico II	Naples	Italy
10	A.O.U.P - Università degli Studi di Palermo	Palermo	Italy
11	University of Rome La Sapienza	Roma	Italy
12	Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk	Bialystok	Poland
13	Specjalistyczna Przychodnia Lekarska Medicus	Chorzow	Poland
14	Gdańskie Centrum Zdrowia Sp. z o.o.	Gdansk	Poland
15	NZOZ Medicus	Gostynin	Poland
16	ATOPIA - Specjalistyczna Przychodnia Medyczna	Krakow	Poland
17	Centrum Medyczne Plejady	Krakow	Poland
18	Gabinet Lekarski Bartosz Korczowski	Rzeszow	Poland
19	Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O	Tarnow	Poland
20	Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.	Zawadzkie	Poland
21	KK Women's and Children's Hospital	Singapore	Singapore
22	Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic	Singapore	Singapore
23	Mount Elizabeth Medical Centre - The Child and Allergy Clinic	Singapore	Singapore
24	National University Hospital	Singapore	Singapore
25	Hospital de Poniente	Almeria	Spain
26	EBA Centelles	Barcelona	Spain
27	Hospital de Nens	Barcelona	Spain
28	Hospital Quirónsalud	Barcelona	Spain
29	Hospital Teresa Herrera	Coruna	Spain
30	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia	Spain
31	Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital	Aylesbury	United Kingdom
32	Northern Devon Healthcare NHS Trust, North Devon District Hospital	Barnstaple	United Kingdom
33	Burton Hospitals NHS Foundation Trust, Queen's Hospital	Burton upon Trent	United Kingdom
34	Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital	Carshalton	United Kingdom
35	Royal Devon and Exeter NHS Foundation Trust	Exeter	United Kingdom
36	Medway NHS Foundation Trust, Medway Maritime Hospital	Gillingham	United Kingdom
37	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth	United Kingdom
38	Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust	King's Lynn	United Kingdom
39	The Leeds Teaching Hospitals NHS Trust	Leeds	United Kingdom
40	Chelsea and Westminster Hospital NHS Foundation Trust	London	United Kingdom
41	King's College Hospital NHS Foundation Trust	London	United Kingdom
42	Plymouth Hospitals NHS Trust, Derriford Hospital	Plymouth	United Kingdom

Sponsors and Collaborators

Nestlé

Investigators

Study Chair: Maryam Olesen, Nestlé Health Science Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT03085134

Other Study ID Numbers:

16.08.CLI

First Posted:

Mar 21, 2017

Last Update Posted:

Jul 23, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Milk Hypersensitivity

Study Results

No Results Posted as of Jul 23, 2019