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Growth of Infants Fed a New Term Infant Formula

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: NCT03090360
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Infant formula (CF) Dietary Supplement: Infant Formula (EF) Not Applicable

Detailed Description:
Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Growth of Infants Fed a New Term Infant Formula With a Prebiotic
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : May 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo comparator (Control)
Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.
Dietary Supplement: Infant formula (CF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.

Experimental: Experimental Formula (Test)
Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.
Dietary Supplement: Infant Formula (EF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.

No Intervention: Breastfed reference group
Breastfed reference group



Primary Outcome Measures :
  1. Growth [ Time Frame: 120 days ]
    Growth (weight gain velocity)


Secondary Outcome Measures :
  1. Growth [ Time Frame: Every month up to 6 months of age ]
    Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group

  2. Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency) [ Time Frame: Every month up to 6 months of age ]
    Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)

  3. GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake) [ Time Frame: Every month up to 6 months of age ]
    GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake)

  4. Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR) [ Time Frame: Every month up to 4 months of age ]
    Fecal microbiota composition, diversity, and abundance

  5. Fecal markers (pH, fecal organic acids, and protein markers of gut health) [ Time Frame: Every month up to 4 months of age ]
    Fecal markers (pH, fecal organic acids, and protein markers of gut health)

  6. Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing) [ Time Frame: Up to 3 months of age ]
    Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)

  7. Adverse events / Morbidity [ Time Frame: 180 days ]
    Adverse events / Morbidity



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent signed and dated
  2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
  3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
  4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
  5. Infants whose parent(s)/LAR have a working freezer.
  6. Healthy term, singleton infant at birth.
  7. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
  8. At enrollment, birth weight ≥ 2500g and ≤ 4500g.
  9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.

Exclusion Criteria:

  1. Infants with conditions requiring infant feedings other than those specified in the protocol.
  2. Infants receiving complementary foods or liquids.
  3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
  4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
  5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

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): NCT03090360


Locations
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Belgium
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
UZ Brussel
Brussel, Belgium
Kinderartsen Huis5
Hasselt, Belgium, 3500
Clinique Ste Elisabeth
Namur, Belgium
CHwapi
Tournai, Belgium
Italy
Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico
Milano, Italy
AOUP "Paolo Giaccone"
Palermo, Italy
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Philippe Alliet Kinderartsen Huis 5

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03090360    
Other Study ID Numbers: 16.07.INF
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 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 Nestlé:
Healthy babies
Infant formula
Growth