A Double Blinded Randomized Feasibility Trial on the Use of Plant Based Omega-3-Fatty Acids (Flaxseed) to Improve Inflammation Driven Pain Outcomes in Children with Sickle Cell Anemia - PROJECT SUMMARY/ ABSTRACT Sickle cell disease (SCD) affects millions worldwide, 100,000 individuals in USA, and nearly 1000 children in UAB. Sickle cell anemia (SCA, HbSS or HbSB0 thalassemia) is the most severe form of SCD and is associated with morbidity, mortality, and health care burden. Acute pain is the hallmark complication for SCA, and inflammation is a driver of pain. Opioids are used to treat acute pain but lead to adverse clinical outcomes. Therefore, non-opioid therapies are desperately needed. Recent data and my preliminary data suggest gut microbial dysbiosis is present in SCD. My data also suggests that a different microbiota profile is present in children with SCA pain. Therefore, dietary interventions manipulating the gut microbiome represent a novel therapy for treating SCA pain. Marine based ω3FA (fish oil) decreases pain in children with SCA but its acceptance is limited by its fishy odor and taste. In contrast, plant-based ω 3FA (Flaxseed-FS) has a neutral taste and reduced pain in patients with rheumatoid arthritis. My preliminary tasting trial identified that children with SCA accept FS added products with over 80% of participants expressing a willingness to be contacted for this feasibility study. Therefore, I am proposing a feasibility study of FS trial in children with SCA. My overarching hypothesis is that FS enriched diet will be acceptable, impact the gut microbiome, decrease inflammation, and reduce pain in children with SCA. The focus of this study is to recruit, retain and monitor for side effects of a FS diet in children with SCA (Aim 1) while evaluating changes in gut microbiota profile (Aim 2) and improvement in inflammation driven pain outcomes (Aim 3) on this diet. The applicant has dedicated her career to becoming a physician scientist investigating inexpensive, sustainable nutritional interventions that impact the microbiome and improve inflammation driven outcomes in SCD. To fulfil this long-term goal, she moved to the University of Alabama at Birmingham (UAB) where she has a supportive research environment in the Department of Pediatrics and School of Medicine, including the Center for Clinical and Translational Science (CCTS), Life span sickle cell disease comprehensive research center, UAB microbiome center, the Immunology Institute and the Nutrition and Obesity Research Center. She has assembled an excellent mentorship team, and she plans to complement this mentorship in formal course work including advanced statistics, clinical trials, metagenomics, nutrition, mucosal immunology, and pain psychology. This award will allow her develop expertise in her identified training needs, acquire the skills to transition into a successful independent physician scientist and grow into a leader in the field.
