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Trial record 4 of 431 for:    infant formula

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

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ClinicalTrials.gov Identifier: NCT03085134
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 174 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 : February 22, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085134


Contacts
Contact: Chui Hong Wong (65) 6635 2209 chuihong.wong@rdsg.nestle.com

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Sponsors and Collaborators
Nestlé
Investigators
Study Chair: Maryam Olesen Nestlé Health Science Spain

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03085134     History of Changes
Other Study ID Numbers: 16.08.CLI
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No