ACTIVE_NOT_RECRUITING

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

Conditions

Healthy Growth Organic Bobbie Bobbie Baby Weight Growth Breastfeeding Infant Formula Growth and Tolerance

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-29

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05783037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 11 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days) * Birth weight of ≥ 2,500 g and ≤ 4,500 g * Postnatal age ≤ 11 days at time of enrollment * Singleton * 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, reporting of AEs, and urine collection) * Caregiver willing and able to sign IRB approved informed consent	* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) * 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 * Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin) * Infant receiving prescription medication * Infant with a known history of cow's milk protein allergy, excluding lactose intolerance * Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development * Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder * Caregiver intent to feed non-study formula or solid food during the study

Inclusion Criteria

Exclusion Criteria

* Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days)
* Birth weight of ≥ 2,500 g and ≤ 4,500 g
* Postnatal age ≤ 11 days at time of enrollment
* Singleton
* 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, reporting of AEs, and urine collection)
* Caregiver willing and able to sign IRB approved informed consent

* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
* 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
* Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin)
* Infant receiving prescription medication
* Infant with a known history of cow's milk protein allergy, excluding lactose intolerance
* Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development
* Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder
* Caregiver intent to feed non-study formula or solid food during the study

Contacts and Locations

Principal Investigator

Thomas Lynch, MD

PRINCIPAL_INVESTIGATOR

SPRIM Pro

Study Locations (Sites)

SPRIM Pro

Indian Harbour Beach, Florida, 32937

United States

Collaborators and Investigators

Sponsor: Bobbie Baby, Inc

Thomas Lynch, MD, PRINCIPAL_INVESTIGATOR, SPRIM Pro

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-03-29

Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

Organic
Bobbie
Bobbie Baby
Weight
Growth
Breastfeeding
Infant Formula
Growth and Tolerance

Additional Relevant MeSH Terms

Healthy Growth