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

July 22, 2019 updated by: Nestlé

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Clínico 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and medication use
Time Frame: 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.
12 months
Growth in terms of body weight.
Time Frame: 12 months
Body weight (in kilograms) measured from enrollment until infants are 12 months of age.
12 months
Growth in terms of body length
Time Frame: 12 months
Body length (in centimetres) measured from enrollment until infants are 12 months of age.
12 months
Growth in terms of head circumference
Time Frame: 12 months
Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.
12 months
Digestive tolerance and alleviation of CMPA
Time Frame: 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.
12 months
Compliance to study formula intake
Time Frame: 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.
12 months
Healthcare resource use assessed with Questionnaire
Time Frame: 12 months
Questionnaire completed from enrollment until infants are 12 months of age.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maryam Olesen, Nestlé Health Science Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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