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Trial record 1 of 1 for:    05508750
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Growth and Safety Clinical Trial on a New Infant Formula

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ClinicalTrials.gov Identifier: NCT05508750
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : September 29, 2022
Sponsor:
Collaborators:
IQVIA RDS Inc.
ObvioHealth
Information provided by (Responsible Party):
Jovie USA, LLC

Study Description
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Brief Summary:
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Condition or disease Intervention/treatment Phase
Weight Gain Other: New Infant Formula Other: Commercial Infant Formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
Actual Study Start Date : September 21, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: New Infant Formula
New infant formula for healthy term infants
 Other: New Infant Formula
New infant formula fed daily ad libitum
Active Comparator: Commercial Infant Formula
Standard, commercially available infant formula for healthy term infants
 Other: Commercial Infant Formula
Commercially available infant formula fed daily ad libitum
No Intervention: Human Milk
Breastfed infants serve as a reference group


Outcome Measures
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Primary Outcome Measures :
  1. Weight gain from baseline to 16 weeks feeding [ Time Frame: 16 weeks ]
    Weight gain g/day


Secondary Outcome Measures :
  1. Length gain from baseline to 16 weeks feeding [ Time Frame: 16 weeks ]
    Length gain

  2. Head Circumference gain from baseline to 16 weeks feeding [ Time Frame: 16 weeks ]
    Head Circumference gain

  3. Volume of formula consumed during 3-consecutive day intervals [ Time Frame: 16 weeks ]
    Volume of formula consumed


Other Outcome Measures:
  1. Assessment of AEs [ Time Frame: 16 weeks ]
    AEs reported during the study

  2. Caregiver report of tolerance obtained during 3-consecutive day intervals [ Time Frame: 16 weeks ]
    Caregiver report of fussiness, gassiness, and spitting up

  3. Caregiver report of stool characteristics obtained during 3-consecutive day intervals [ Time Frame: 16 weeks ]
    Caregiver report of stool consistency, color, and frequency

  4. Stool collection for microbiome testing [ Time Frame: 16 weeks ]
    Stool collection for microbiome testing at week 16 of feeding


Eligibility Criteria
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Ages Eligible for Study:   0 Days to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal term infant (37-42 weeks gestation at birth)
  • Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
  • Infant birth weight of ≥2500 g (5.5 lbs.)
  • Healthy Infant
  • Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
  • Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
  • Caregiver willing and able to sign informed consent

Exclusion Criteria:

  • Infant born in multiple birth (i.e., twins, triplets, etc.)
  • Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
  • Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
  • Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
  • Caregiver intent to feed non-study formula or solid food during the study
Contacts and Locations
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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): NCT05508750


Contacts
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Contact: Jan van Marwijk, CEO Jovie USA LLC +1 847-337-2615 j.vanmarwijk@jovieusa.com

Locations
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United States, New York
ObvioHealth Recruiting
New York, New York, United States, 10001
Contact: Parth Shah, Principle Investigator and Medical Director    888-638-6889    joviestudy@obviohealth.com   
Sponsors and Collaborators
Jovie USA, LLC
IQVIA RDS Inc.
ObvioHealth
Investigators
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Principal Investigator: Parth Shah, MD FAPCR ObvioHealth
Study Director: Dawn Ross, Director Clinical Project Management IQVIA RDS Inc.
More Information
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Responsible Party: Jovie USA, LLC
ClinicalTrials.gov Identifier: NCT05508750    
Other Study ID Numbers: IQV-JOV-001
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
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 Jovie USA, LLC:
infant
formula
in-home
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight