Growth and Safety Clinical Trial on a New Infant Formula

Weight Gain Clinical Trial

Official title:

A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508750
• Other study ID #: IQV-JOV-001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Weight Gain

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