Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    JEN/008017
Previous Study | Return to List | Next Study

Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513744
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Analyze & Realize
Information provided by (Responsible Party):
Jennewein Biotechnologie GmbH

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.

Condition or disease Intervention/treatment Phase
Infant Nutrition Dietary Supplement: human milk oligosaccharides Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: infant formula containing five HMOs Dietary Supplement: human milk oligosaccharides
mixture of five different human milk oligosaccharides

No Intervention: infant formula
No Intervention: breast milk group



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. digestive tolerance [ Time Frame: 4 month ]
    stool frequency and consistency

  2. influence of digestion [ Time Frame: 4 month ]
    digestive tolerance parameters ( e.g. rigurgitation, flatulence) will be assessed

  3. influence on behaviour [ Time Frame: 4 month ]
    behavior patterns (e.g.fussiness, cramps, awakings at night) will be assessed

  4. product compliance [ Time Frame: 4 month ]
    intake of infant formula in ml

  5. morbidity [ Time Frame: 4 month ]
    observation of illness

  6. stool microbiota [ Time Frame: 4 month ]
    analysis of the fecal microbiota

  7. HMO composition in breast milk [ Time Frame: 4 month ]
    analysis of HMO composition in mothers breastmilk in the breast-fed arm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 13 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03513744


Locations
Layout table for location information
Germany
Facharzt für Kinder und Jugendmedizin
Mannheim, Germany, 68161
Klinikum Südstadt Rostock
Rostock, Germany, 18059
Italy
ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini
Brescia, Italy, 25123
Ospedale San Raffaele
Milan, Italy, 20132
Spain
Hospital HM Puerta del Sur
Madrid, Spain, 28015
Hospital HM Monteprincipe
Madrid, Spain, 28660
Hospital HM Nuevo Belen
Madrid, Spain, 28938
Hospital Universitario Sant Joan de Reus
Reus, Spain, 43204
Hospital Joan XXII of Tarragona
Tarragona, Spain, 43005
Sponsors and Collaborators
Jennewein Biotechnologie GmbH
Analyze & Realize
Investigators
Layout table for investigator information
Principal Investigator: Frank Jochum, Dr. med. Universitaetsmedizin Berlin, Charité
Layout table for additonal information
Responsible Party: Jennewein Biotechnologie GmbH
ClinicalTrials.gov Identifier: NCT03513744    
Other Study ID Numbers: JEN/008017
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: January 2020

Layout table for additional information
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
Keywords provided by Jennewein Biotechnologie GmbH:
human milk oligosaccharides
infant formula