Today, Bobbie, the organic infant formula company founded and led by moms, announced its first clinical trial, enabling the science-backed brand to double down on research, innovation and unique products and recipes for American parents. The first patient was enrolled the last week of March for a study designed to evaluate the growth, tolerance, and safety of a new infant formula.
As one of the first fully virtual clinical trials in the infant formula industry, Bobbie is optimizing and modernizing the experience with telehealth and a custom-built app for data collection to empower parents to participate and increase accessibility across all the country.
“On the back of last year’s infant formula crisis, science-backed research and domestic innovation in this space are our top priorities at Bobbie. In order to truly reform this industry from the ground up and improve infant formula nutrition standards nationwide, we need to continue to push the status quo on ingredient choices. Our landmark clinical study will allow us to do just that, driving critical findings to bolster Bobbie’s product development and provide US parents and their babies with high quality Organic infant formula,” said Laura Modi, CEO and Co-Founder of Bobbie, and mom of three.
Meanwhile, Bobbie Labs, the research and development hub of the business, is gearing up to launch the company’s second product, Bobbie Organic Gentle, in Spring 2023, expanding the Bobbie product line to serve more parents and their babies across the U.S. It will be the first and only American-made, EU-style organic tolerance product made with 100% lactose. Lactose is the primary source of carbohydrate found in breast milk and provides energy to fuel growth, yet nearly 90% of all tolerance formulas in the U.S. use corn syrup solids, rice syrup or corn derivatives like maltodextrin as a carb source.
"Parents are at the forefront of everything we do at Bobbie and this study is no exception. By thoughtfully dovetailing business-like efficiency and research expertise with a mother’s compassion, we are upleveling how we collect clinical data and shaping the future of formula innovation. The first week of enrollment saw conversion rates that far outpaced the industry average and we will continue to lean into our vision of empowering parents to contribute to research that is critical for our babies," said Dani Addison, Director, Clinical Strategy & Research Operations at Bobbie and mom of two.
As an extension of the company’s focus on innovation, Bobbie Labs is investing in academic research within three critical areas of infant feeding: nutrition, society, and planet, to push the industry forward and support new parents. Studies are funded through an open request for research proposals; applications are being accepted until April 14, 2023.
The 16 week, double-blind, randomized, controlled trial is designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The trial is IRB approved and is currently recruiting across the continental United States and will include both formula fed and breastfed infants. To learn more, or apply, please visit: https://www.hibobbie.com/pages/bobbie-clinical-study.
This study has been designed in accordance with Good Clinical Practice guidelines. Additional information can be found on www.clinicaltrials.gov. For more information on enrollment, contact Recruiting Support at 1-888-549-1216 ext. 1003.