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Completed

NCT Number: NCT03085134

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

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.

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Key information

Conditions

Cow's Milk Protein Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint Luc, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test infant formula with HMOs

Other

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.

Control infant formula without HMOs

Other

Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Growth in terms of body weight.

    Time frame: 12 months

    Body weight (in kilograms) measured from enrollment until infants are 12 months of age.

  3. Growth in terms of body length

    Time frame: 12 months

    Body length (in centimetres) measured from enrollment until infants are 12 months of age.

  4. Growth in terms of head circumference

    Time frame: 12 months

    Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.

  5. 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.

  6. 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.

  7. Healthcare resource use assessed with Questionnaire

    Time frame: 12 months

    Questionnaire completed from enrollment until infants are 12 months of age.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: CINNAMON

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 21, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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