For Immediate Release
CRO serves as the Statistical and Data Coordinating Center for NIH funded study
Chapel Hill, NC ̶ March 4, 2016 ̶ Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, is part of a newly published clinical trial that found that children who consumed peanut-containing foods regularly from infancy to age five and then avoided peanut for one year did not become allergic to peanut. This result strongly suggests that the benefit of early peanut consumption is long-lasting. The study, published in the New England Journal of Medicine, was funded by the National Institute of Allergy and Infectious Diseases, part National Institutes of Health.
This study was a follow-up to the Learning Early About Peanut Allergy (LEAP) study, which tested the hypothesis that early introduction of peanut protein in the diets of children at risk for developing peanut allergy could lead to a reduction in peanut allergy at age 5. The LEAP study demonstrated an overall 81 percent reduction of peanut allergy in children who began early, continuous consumption of peanut-containing foods, compared to those who avoided such foods.
Both studies were supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and conducted by researchers in NIAID’s Immune Tolerance Network (ITN).
“For many years, physicians had recommended that parents avoid giving infants and young children potentially allergenic foods, such as peanut,” said Michelle Sever, Ph.D., Senior Research Scientist/Co-Principal Investigator, Rho. “Yet the incidence of peanut allergy in children has doubled since 1997, leading researchers to question this guidance. The one year follow on of the LEAP study has demonstrated that once early introduction of peanut protein in the diet has been established, consumption could be stopped for at least one year without impacting a child’s ability to tolerate peanut.”
As part of Rho’s federal market work, the company serves as the Statistical and Data Coordinating Center for the NIAID Immune Tolerance Network, supporting approximately 25 active clinical trials and related research studies on allergic diseases, lupus nephritis, multiple sclerosis, type 1 diabetes, transplantation and more. Rho provides support for statistical analysis, safety monitoring, data management, as well as supporting study protocol and manuscript development.
Approximately 30 Rho employees have provided support for the LEAP study, including researchers Michelle Sever, PhD and Kaitie Lawson, MS, who are both co-authors of the published results.
This work was funded in part by NIAID under award numbers NO1-AI-15416, UM1AI109565, HHSN272200800029C and UM2AI117870. Other organizations providing support include Food Allergy Research & Education, the Medical Research Council and Asthma UK Centre, and the UK Department of Health. The study data and results can be found on ITN TrialShare (www.itntrialshare.org) an open-access website that hosts studies conducted by the ITN. Additional details are available at ClinicalTrials.gov using the identifier NCT00329784 for LEAP and NCT01366846 for LEAP-On.
To learn more about Rho, please visit www.rhoworld.com.
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 32 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.