Study on a new organic cow's milk-based infant formula for healthy term infants
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
NA · Bobbie Baby, Inc · NCT05783037
This study is testing a new organic cow's milk-based infant formula to see how well it helps healthy babies grow compared to a regular organic formula and breast milk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 335 (estimated) |
| Ages | 0 Days to 11 Days |
| Sex | All |
| Sponsor | Bobbie Baby, Inc (industry) |
| Locations | 1 site (Indian Harbour Beach, Florida) |
| Trial ID | NCT05783037 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the growth, tolerance, and safety of a new organic cow's milk-based infant formula in healthy term infants over a 16-week period. It is a double-blind, randomized, controlled trial comparing the growth rates of infants fed the new formula to those fed an existing commercial organic formula, as well as a group of breastfed infants for reference. The study is designed following Good Clinical Practice guidelines to ensure the safety and efficacy of the formula.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy term infants aged 11 days or younger who are either exclusively breastfed or exclusively formula-fed.
Not a fit: Infants with medical complications or growth issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new infant formula option that supports healthy growth in infants.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating infant formulas, but this specific formula is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Indian Harbour Beach, Florida
- SPRIM Pro — Indian Harbour Beach, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Thomas Lynch, MD — SPRIM Pro
- Study coordinator: Recruiting Support
- Email: bobbiesupport@sprim.net
- Phone: 1-212-227-1905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Growth, Organic, Bobbie, Bobbie Baby, Weight, Growth, Breastfeeding, Infant Formula