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Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

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ClinicalTrials.gov Identifier: NCT03513744
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jennewein Biotechnologie GmbH

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE November 19, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
assessment of body weight (in grams) of term infants [ Time Frame: 4 month ]
growth, assessed by body weight gain, of term infants from enrollment to 4 month of life
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03513744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • assessment of body length (in centimeter) of term infants [ Time Frame: 4 month ]
    growth, assessed as body length, of term infants from enrollment to 4 month of life
  • assessment of head circumference (in centimeter) of term infants [ Time Frame: 4 month ]
    growth, assessed as head circumference, of term infants from enrollment to 4month of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 19, 2018)
  • digestive tolerance [ Time Frame: 4 month ]
    stool frequency and consistency
  • influence of digestion [ Time Frame: 4 month ]
    digestive tolerance parameters ( e.g. rigurgitation, flatulence) will be assessed
  • influence on behaviour [ Time Frame: 4 month ]
    behavior patterns (e.g.fussiness, cramps, awakings at night) will be assessed
  • product compliance [ Time Frame: 4 month ]
    intake of infant formula in ml
  • morbidity [ Time Frame: 4 month ]
    observation of illness
  • stool microbiota [ Time Frame: 4 month ]
    analysis of the fecal microbiota
  • HMO composition in breast milk [ Time Frame: 4 month ]
    analysis of HMO composition in mothers breastmilk in the breast-fed arm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
Official Title  ICMJE Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
Brief Summary The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
Detailed Description

The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.

As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Infant Nutrition
Intervention  ICMJE Dietary Supplement: human milk oligosaccharides
mixture of five different human milk oligosaccharides
Study Arms  ICMJE
  • Experimental: infant formula containing five HMOs
    Intervention: Dietary Supplement: human milk oligosaccharides
  • No Intervention: infant formula
  • No Intervention: breast milk group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Singleton birth
  • Full-term infant (37 - 42 weeks of gestational age)
  • APGAR score of 9 or 10
  • Birth weight 2500 - 4500 g

Exclusion Criteria:

  • clinically significant condition/ disorder
  • Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
  • readmission to hospital (except for hyperbilirubinemia)
  • allergy to cow's milk
  • participation in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 13 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kaja Parschat, Ph.D + 4922249197344 katja.parschat@jennewein-biotech.de
Contact: Stefan Jennewein, Ph.D +4922249894501 stefan.jennewein@jennewein-biotech.de
Listed Location Countries  ICMJE Germany,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03513744
Other Study ID Numbers  ICMJE JEN/008017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennewein Biotechnologie GmbH
Study Sponsor  ICMJE Jennewein Biotechnologie GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frank Jochum, Dr. med. Universitaetsmedizin Berlin, Charité
PRS Account Jennewein Biotechnologie GmbH
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP