(P08-012-23) Evaluation of the Lifestyle Eating and Performance (LEAP) Program To Manage Symptoms and Quality of Life for Irritable Bowel Syndrome (IBS)

Objectives: To examine the effectiveness of the Lifestyle Eating and Performance (LEAP) program in improving symptoms and quality of life (QoL) in individuals with irritable bowel syndrome (IBS).

Methods: We analyzed preliminary data from a prospective, single-arm study (ClinicalTrials.gov ID: NCT05178017), including 16 adults (14 women and 2 men) diagnosed with IBS. Before its initiation, the study was approved by an independent Institutional Review Board (IRB). Oxford Biomedical Technologies, a CLIA-certified laboratory, performed the Leukocyte Activation Assay-MRT (LAA-MRT®) analysis from collected venous blood. LAA-MRT® was conducted using Sony EC 800 Dual-Mode Flow Cytometry Systems. The LEAP program is a multiphase personalized eating plan methodically prepared for each participant. Foods for each phase were selected based on the degree of LAA-MRT® immune reactivity and clinical response, starting with the least immune-reactive foods. Subsequently, foods were added in a nutritionally balanced manner at each phase. A trained registered dietitian nutritionist (RDN) conducted the virtual counseling sessions. Self-reporting outcome assessments: Quality of life [IBS-36-QoL] consist of 36 items, and Global Symptom Survey (GSS) contains four domains: a) constitutional (7 items), b) emotional/ mental (7 items), c) musculoskeletal (7 items), and d) digestive (10 items).

Results: The participant’s mean age was 53.7±18.9 years, and their BMI was 28.7±7.6 kg/m². At 12 weeks, there were significant improvements from pre-dietary intervention in IBS-36-QoL [101.5±43.6 vs. 34.6±33.3, t(15)=4.705, p< 0.001, 95% CI (36.6, 97.2), d=1.17]; GSS: a) constitutional [10.6±6.0 vs. 5.2±5.9, t(15)=3.701, p=0.002, 95% CI (2.3, 8.6), d=0.92]; b) emotional/ mental [8.6±6.3 vs. 4.2±5.8, t(15)=2.890, p=0.011, 95% CI (1.2, 7.7), d=0.72]; c) musculoskeletal [7.6±4.7 vs. 3.7±5.0, t(15)=3.769, p=0.002, 95% CI (1.7, 6.0), d=0.94]; and d) digestive [16.9±6.9 vs. 4.9±4.3, t(15)=6.025, p< 0.001, 95% CI (7.7, 16.2), d=1.50].

Conclusions: Removing dietary triggers identified by the LAA-MRT® provided symptomatic relief and improved QoL among individuals with IBS. The LEAP program, with the guidance of an RDN, was effective as a personalized nutritional therapy for managing IBS.

Funding Sources: Oxford Biomedical Technologies, Inc.