Study Protocol: Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)

Abstract

Abstract Objectives Cytokine levels may be an important factor in the metabolic pathways of irritable bowel syndrome (IBS) pathophysiology. Current therapies for IBS are often ineffective, underlining the need for alternative treatment options. Studies on personalized dietary approaches for the treatment of IBS are scarce. We plan to evaluate the effectiveness of the Lifestyle Eating and Performance (LEAP) program to improve cytokines levels, gastrointestinal symptoms, and quality of life with three months of treatment in individuals with IBS. Methods We will conduct a prospective single-arm study (NCT05178017), including 60 adults (age 18–75 years) with diagnosis of IBS. The study received approval from an independent Institutional Review Board (IRB). In-person and virtual sessions will be conducted at baseline and follow-up visits (day 15, 30, 45, 60, and 90). Intervention: A trained dietitian will administer the virtual counseling sessions. The LEAP program is a multiphase tailored eating plan that is methodically prepared for individuals with IBS. Foods for each phase are selected based on the degree of Leukocyte Activation Assay-MRT (LAA-MRT®) immune reactivity and clinical response, starting with the least immune reactive foods, and subsequently foods will be added in a nutritionally balanced manner. Outcome Assessments: Gastrointestinal symptoms [IBS-Symptom Severity Scale (IBS-SSS), IBS-Adequate Relief (IBS-AR), IBS-Global Improvement Scale (IBS-GIS), and Global Symptom Survey (GSS)]; quality of life [IBS-36 Quality of Life]; anthropometrics and vital signs [body mass index (BMI), waist and hip circumferences, and blood pressure)]; dietary intake [Walter Willett's food frequency questionnaire (Harvard University) and food symptom diary]. Oxford Biomedical Technologies, a CLIA-certified laboratory, will perform the LAA-MRT® and cytokine analysis from collected venous blood. LAA-MRT® will be conducted using Sony EC 800 Dual-Mode Flow Cytometry Systems. Cytokine panel will include (IL-1β, IL-6, IL-8, IL-10, IL-12, IL-17, and TNF-α) and analyzed using a Bio-Plex 200 System (Bio-Rad). Results N/A (protocol abstract) Conclusions This study will generate evidence and clinical relevance of diet-induced inflammation that could explain changes in biomarkers for IBS and improved treatment outcomes. Funding Sources Oxford Biomedical Technologies.