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Growth and Tolerance Trial on Infant Formula With HMO (Stardust)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066413
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
FrieslandCampina

Brief Summary:
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Condition or disease Intervention/treatment Phase
Healthy Growth Other: Standard infant formula Other: Infant formula supplemented with HMO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : September 23, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Breastfed group
Non-randomized breastfed reference group
Placebo Comparator: Control formula
Group receiving standard infant formula
Other: Standard infant formula
Standard infant formula

Active Comparator: Formula with HMO
Group receiving standard infant formula supplemented with HMO
Other: Infant formula supplemented with HMO
Infant formula supplemented with HMO




Primary Outcome Measures :
  1. Growth [ Time Frame: From enrollment until end of the 3 month-study ]
    Infant growth measured as body weight gain per day


Secondary Outcome Measures :
  1. Weight [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    Infant weight (kg)

  2. Recumbent length [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    Infant length (cm and cm/day)

  3. Head circumference [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    Head circumference (cm and cm/day)

  4. Anthropometry z-scores [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference

  5. Formula tolerance [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit

  6. Gastro-intestinal comfort [ Time Frame: Monthly, from enrollment until end of the 3 month-study ]
    Parents are asked to keep a diary 3 days prior to each monthly study visit including questions on gastro-intestinal symptoms (e.g. cramps, constipation, vomiting) and crying behavior



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational age ≥ 37 weeks
  • Birth weight ≥ 2500 grams
  • No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
  • Boys and girls
  • Recruited < 1 month/age
  • Being available for follow up until the age of 4 months
  • Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion Criteria:

  • Gestational age <37 weeks
  • Birth weight <2500 grams
  • Severe acquired or congenital diseases, mental or physical disorders
  • Illness at screening/ inclusion
  • Incapability of parents/caregivers to comply with the study protocol
  • Received antibiotics within the first month of life
  • Not tolerating standard cow's milk based infant formula
  • Participation in another clinical trial
  • Maternal illicit drug use during pregnancy or post-partum period
  • Parent/caregiver does not have a cell phone to use for filling out questionnaires

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): NCT04066413


Contacts
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Contact: Dianne Delsing, PhD +31653598111 dianne.delsing@frieslandcampina.com
Contact: Inge Thijs-Verhoeven, MSc +31613248135 Inge.Thijs-Verhoeven@frieslandcampina.com

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3026
Contact: James E Heubi, MD, Prof    513-636-9776    James.Heubi@cchmc.org   
Contact: Andre Hawkins, MSc       Andre.Hawkins@cchmc.org   
Principal Investigator: James E Heubi, MD, PhD         
Sponsors and Collaborators
FrieslandCampina
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Responsible Party: FrieslandCampina
ClinicalTrials.gov Identifier: NCT04066413    
Other Study ID Numbers: Stardust
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FrieslandCampina:
infant formula
human milk oligosaccharide
HMO
growth