MENLO PARK, Calif., Oct. 6, 2020 /PRNewswire/ -- SpoonfulOne, a food allergy protection company, is launching a first-of-its-kind digital, randomized, controlled trial with the Duke Clinical Research Institute (DCRI) to evaluate the ability to protect against food allergies with routine feeding of the most common food allergy proteins during infancy and toddlerhood. The trial is expected to begin in December with the recruitment of 1,500 healthy babies between four to six months of age. Study parameters will support new feeding guidelines recommending the early introduction of potential food allergens for food allergy prevention, glean parental experiences of early introduction in infant feeding, and support the evidence showing SpoonfulOne as the category-leading solution for food allergy prevention.
The study will be led by Principal Investigator, pediatric allergist, David Jeong, MD, and co-investigated by DCRI's Christoph Hornik, MD, PhD, MPH, who specializes in neonatal and infant therapeutics. In addition, SpoonfulOne assembled an executive committee of advisors to oversee the study including pediatric allergists, digital health experts, food allergy parents, and community pediatricians.
"Our understanding of food allergy protection has grown by leaps and bounds in the past few years, with landmark studies establishing the importance and safety of early introduction and sustained feeding of a diverse diet. However, we know in a real-world setting, it may not be so easy to accomplish. The results of this study have the potential to show how a comprehensive commercial food product can help make food allergy prevention easy for parents," said Dr. Jeong.
Cutting Edge Technology
Designed to recruit infants from across the U.S., the siteless study will be conducted using a mobile platform providing ease and convenience to parent participants and maintain safety amid the COVID-19 pandemic. The application will enable parents to complete their study questionnaires and e-diaries directly into the mobile application at their convenience and will be a source for educational content from leading pediatric experts. Participants will receive SpoonfulOne products in the mail and complete app-based education modules, surveys, and inputs for data collection - no in-person study visits are required.
"Our hypothesis is that we can employ digital health tools and solutions to confirm a reduction in sensitization and subsequent development of food allergy in infants as a result of proactively feeding common allergens leveraging SpoonfulOne. We already know, based on global, landmark research that food allergy protection is more than possible, it's essential," said SpoonfulOne Chief Medical Officer, pediatrician, Wendy Sue Swanson, MD, MBE.
Participants will be parents to healthy, full-term babies without a diagnosis of food allergy. The study will recruit to fill 30 percent of the participants with a diagnosis of eczema, as those babies are at the highest risk for developing food allergies. Participants will be 1:1 randomized between the intervention and control group. The active serving arm (n=750) will receive SpoonfulOne products once daily by mouth for 18 months. The control arm (n=750) will be fed on a standard diet only, without SpoonfulOne for 12 months.
The objective is to investigate the ability of parents to protect their babies from developing food allergies by getting common food allergens into the diet routinely throughout infancy and toddlerhood.
"DCRI brings decades of experience in pediatric medicine and a focus on patient-centered, pragmatic trial design to this trial," said Dr. Hornik. "We look forward to working with SpoonfulOne to evaluate the ability to protect against food allergies with routine feeding of the most common food allergy proteins and, ultimately, to share knowledge that may advance pediatric clinical practice and improve the lives of pediatric patients."
Food Allergy Prevention Research
SpoonfulOne is the only food allergy prevention company based on global landmark research from the LEAP and EAT studies in addition to proprietary research that showed that the diverse mix of ingredients in SpoonfulOne changed the immune system and dramatically reduced levels of allergy-triggering antibodies when fed consistently over the course of one year. In an independent study conducted at Northwestern University Feinberg School of Medicine of over 700 infants and more than 8,000 feedings of SpoonfulOne, there were zero reported allergic reactions. These findings were subsequently published in Pediatric Allergy and Immunology.
Given this global body of evidence, the U.S. Food and Drug Administration and the National Institute of Allergy and Infectious Diseases have formally supported the early introduction of potential allergens in an infant's diet.
SpoonfulOne is a revolutionary, science-backed line of nutritional products that make food allergy protection possible. Each serving of pediatrician recommended SpoonfulOne includes the food groups responsible for over 90% of food allergies. SpoonfulOne was invented by Before Brands and globally renowned pediatric allergist, Dr. Kari Nadeau, who also directs the Sean N. Parker Center for Allergy and Asthma Research at Stanford University's School of Medicine. The company headquarters in Menlo Park, CA, and has been backed since inception by Gurnet Point Capital along with a consortium of families from the food allergy community. In 2019, a global partnership was formed with Nestlé Health Science in which Nestlé acquired the non-U.S. rights to commercialize SpoonfulOne around the world. Learn more at: www.spoonfulone.com.