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Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula

NCT05783037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2026-02-05

No results posted yet for this study

Summary

The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

Conditions

  • Healthy Growth

Interventions

OTHER

New Organic Infant Formula

New organic infant formula fed daily ad libitum

OTHER

Commercial Organic Infant Formula

Commercially available organic infant formula fed daily ad libitum

Sponsors & Collaborators

  • Bobbie Baby, Inc

    lead INDUSTRY

Principal Investigators

  • Thomas Lynch, MD · SPRIM Pro

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
11 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2025-12-04
Completion
2025-12-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783037 on ClinicalTrials.gov