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Trial record 1 of 1 for:    JEN/008017
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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

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.


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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 : December 2019
Estimated Study Completion Date : March 2020

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

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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


Contacts
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Contact: Kaja Parschat, Ph.D + 4922249197344 katja.parschat@jennewein-biotech.de
Contact: Stefan Jennewein, Ph.D +4922249894501 stefan.jennewein@jennewein-biotech.de

Locations
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Germany
Facharzt für Kinder und Jugendmedizin Recruiting
Mannheim, Germany, 68161
Contact: Falko Panzer, Dr.         
Klinikum Südstadt Rostock Recruiting
Rostock, Germany, 18059
Contact: Manfred Olbertz, Dr.         
Italy
ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini Recruiting
Brescia, Italy, 25123
Contact: Gaetano Chirico         
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Graziano Barera, Prof.         
Spain
Hospital HM Puerta del Sur Recruiting
Madrid, Spain, 28015
Contact: Alejandro Lopez Dr. Escobar, Dr         
Hospital HM Monteprincipe Recruiting
Madrid, Spain, 28660
Contact: Alejandro López, Dr.         
Hospital HM Nuevo Belen Recruiting
Madrid, Spain, 28938
Contact: Alejandro López, Dr.         
Hospital Universitario Sant Joan de Reus Recruiting
Reus, Spain, 43204
Contact: Escribano Joaquin, Dr.         
Hospital Joan XXII of Tarragona Recruiting
Tarragona, Spain, 43005
Contact: Ricardo Closa, Dr.         
Sponsors and Collaborators
Jennewein Biotechnologie GmbH
Investigators
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Principal Investigator: Frank Jochum, Dr. med. Universitaetsmedizin Berlin, Charité

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Responsible Party: Jennewein Biotechnologie GmbH
ClinicalTrials.gov Identifier: NCT03513744     History of Changes
Other Study ID Numbers: JEN/008017
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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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