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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05508750
Other study ID # IQV-JOV-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2022
Est. completion date January 2, 2024

Study information

Verified date January 2024
Source Jovie USA, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date January 2, 2024
Est. primary completion date January 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days to 14 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
New Infant Formula
New infant formula fed daily ad libitum
Commercial Infant Formula
Commercially available infant formula fed daily ad libitum

Locations

Country Name City State
United States ObvioHealth New York New York

Sponsors (3)

Lead Sponsor Collaborator
Jovie USA, LLC IQVIA RDS Inc., ObvioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of AEs AEs reported during the study 16 weeks
Other Caregiver report of tolerance obtained during 3-consecutive day intervals Caregiver report of fussiness, gassiness, and spitting up 16 weeks
Other Caregiver report of stool characteristics obtained during 3-consecutive day intervals Caregiver report of stool consistency, color, and frequency 16 weeks
Other Stool collection for microbiome testing Stool collection for microbiome testing at week 16 of feeding 16 weeks
Primary Weight gain from baseline to 16 weeks feeding Weight gain g/day 16 weeks
Secondary Length gain from baseline to 16 weeks feeding Length gain 16 weeks
Secondary Head Circumference gain from baseline to 16 weeks feeding Head Circumference gain 16 weeks
Secondary Volume of formula consumed during 3-consecutive day intervals Volume of formula consumed 16 weeks
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