Cow's Milk Protein AllergyCINNAMONNCT03085134
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
A study testing Test infant formula with HMOs in people with Cow's Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 42 sites in 7 countries.
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… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Test infant formula with HMOs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 42 sitesin 7 countries
- Study dates
- 22 Feb 2017to 8 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 7 countries.
42 sites in 7 countries
United Kingdom12 sites
Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital
Aylesbury
Northern Devon Healthcare NHS Trust, North Devon District Hospital
Barnstaple
Burton Hospitals NHS Foundation Trust, Queen's Hospital
Burton-on-Trent
Epsom and St Helier University Hospitals NHS Trust, St Helier University Hospital
Carshalton
Royal Devon and Exeter NHS Foundation Trust
Exeter
Medway NHS Foundation Trust, Medway Maritime Hospital
Gillingham
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
Queen Elizabeth Hospital, King's Lynn NHS Foundation Trust
Kings Lynn
The Leeds Teaching Hospitals NHS Trust
Leeds
Chelsea and Westminster Hospital NHS Foundation Trust
London
King's College Hospital NHS Foundation Trust
London
Plymouth Hospitals NHS Trust, Derriford Hospital
Plymouth
Poland9 sites
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
Bialystok
Specjalistyczna Przychodnia Lekarska Medicus
Chorzów
Gdańskie Centrum Zdrowia Sp. z o.o.
Gdansk
NZOZ Medicus
Gostynin
ATOPIA - Specjalistyczna Przychodnia Medyczna
Krakow
Centrum Medyczne Plejady
Krakow
Gabinet Lekarski Bartosz Korczowski
Rzeszów
Alergo-Med Specjalistyczna Przychodnia Lekarska SP. Z.O.O
Tarnów
Centrum Medyczne Lucyna Andrzej Dymek NZOZ S.C.
Zawadzkie
Spain6 sites
Hospital Teresa Herrera
A Coruña
Hospital de Poniente
Almería
EBA Centelles
Barcelona
Hospital de Nens
Barcelona
Hospital Quirónsalud
Barcelona
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Italy5 sites
A.O.U Ospedali Riuniti
Ancona
Ospedale Luigi Sacco, Polo Universitario
Milan
University of Naples Federico II
Naples
A.O.U.P - Università degli Studi di Palermo
Palermo
University of Rome La Sapienza
Roma
Singapore4 sites
KK Women's and Children's Hospital
Singapore
Mount Elizabeth Medical Centre - Chiang Children's Allergy & Asthma Clinic
Singapore
Mount Elizabeth Medical Centre - The Child and Allergy Clinic
Singapore
National University Hospital
Singapore
Belgium3 sites
Cliniques Universitaires Saint Luc
Brussels
University Hospital Brussels
Brussels
CHC clinique de l'Esperance
Montegnée
Hungary3 sites
Clinexpert Gyogycentrum
Budapest
Bagoly Egeszseghaz
Kecskemét
Csolnoky Ferenc Korhaz
Veszprém
About this study
Official title: 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.
Read the 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.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Test infant formula with HMOs, Control infant formula without HMOs
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test infant formula with HMOsOther
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
Control infant formula without HMOsOther
Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.
| Study group | Role | What they receive |
|---|---|---|
| Test infant formula with HMOs | Experimental | Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite. Receives: Other: Test infant formula with HMOs |
| Control infant formula without HMOs | Active comparator | Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite Receives: Other: Control infant formula without HMOs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth expressed as weight gain in grams per day
Body weight measured from enrollment to 4 months of study formula intake
Measured: 4 months
Secondary outcomes (7)
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.
Measured: 12 months
Growth in terms of body weight.
Body weight (in kilograms) measured from enrollment until infants are 12 months of age.
Measured: 12 months
Growth in terms of body length
Body length (in centimetres) measured from enrollment until infants are 12 months of age.
Measured: 12 months
Growth in terms of head circumference
Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.
Measured: 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.
Measured: 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.
Measured: 12 months
Healthcare resource use assessed with Questionnaire
Questionnaire completed from enrollment until infants are 12 months of age.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start22 Feb 2017
- Primary completion7 Aug 2018
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maryam Olesen, Study chair, Nestlé Health Science Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085134
- Sponsor's protocol ID
- 16.08.CLI
- Acronym
- CINNAMON
- Status last verified
- Jul 2019
- First submitted
- 28 Feb 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)
- ClinicalTrials.gov ID
- NCT03085134
- Acronym / sponsor ID
- CINNAMON / 16.08.CLI
- Conditions
- Cow's Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test infant formula with HMOs | Experimental | Other: Test infant formula with HMOsExtensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite. |
| Control infant formula without HMOs | Active comparator | Other: Control infant formula without HMOsExtensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test infant formula with HMOsExtensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA. | Other | Test infant formula with HMOs |
| Control infant formula without HMOsExtensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA. | Other | Control infant formula without HMOs |
Primary outcome
Growth expressed as weight gain in grams per day
Time frame: 4 months
Body weight measured from enrollment to 4 months of study formula intake
7 secondary outcomes
Safety and medication use
Time frame: 12 months
Growth in terms of body weight.
Time frame: 12 months
Growth in terms of body length
Time frame: 12 months
Growth in terms of head circumference
Time frame: 12 months
Digestive tolerance and alleviation of CMPA
Time frame: 12 months
Compliance to study formula intake
Time frame: 12 months
Healthcare resource use assessed with Questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Olesen study chair
Nestlé Health Science Spain
42 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test infant formula with HMOs in people with Cow's Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 42 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United Kingdom, Poland, Spain, Italy, Singapore and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth expressed as weight gain in grams per day (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.