Core Insights - Biomerica, Inc. has announced the publication of a large multicenter clinical trial demonstrating the effectiveness of its inFoods® IBS diagnostic-guided therapy in managing Irritable Bowel Syndrome (IBS) symptoms [1][3][10] Study Overview - The clinical trial was randomized, multicenter, double-blind, and placebo-controlled, evaluating the inFoods® IBS test's ability to identify patient-specific dietary triggers and guide targeted food elimination [2][4] - The study involved 223 IBS patients across eight major U.S. academic medical centers, including renowned institutions like Mayo Clinic and Harvard Beth Israel Deaconess Medical Center [4] Key Findings - Patients following the inFoods® IBS-guided elimination diet experienced significantly greater symptom relief, with 59.6% achieving the FDA-defined target for abdominal pain reduction compared to 42.1% in the control group [9] - Particularly strong results were noted in difficult-to-treat IBS subtypes, with 67.1% of IBS-C patients and 66.0% of IBS-M patients responding positively to the treatment [9] Methodology and Innovation - The inFoods® IBS assay utilizes a proprietary discriminatory p-value method to identify foods causing abnormal IgG responses unique to IBS patients, allowing for a more focused dietary approach [7][10] - The study design addressed limitations of previous research by employing an IBS-specific food panel and robust statistical methodology, enhancing the reliability of the findings [6][10] Clinical Implications - The results support a shift towards precision medicine in gastrointestinal care, where individualized biological markers guide tailored treatment decisions rather than generalized approaches [12][11] - The inFoods® IBS protocol typically results in the elimination of only 2 to 4 foods per patient, making it a more practical and sustainable option compared to broader dietary strategies like the low-FODMAP diet [8][10] Recognition and Future Outlook - The inclusion of inFoods® IBS in Biotherapeutics Quarterly highlights the growing recognition of Biomerica's innovation among healthcare professionals [13] - The study's outcomes underscore the potential of diagnostic-guided dietary strategies to address unmet clinical needs, particularly for IBS-M patients, for whom no FDA-approved medications currently exist [11][12]
Biomerica's inFoods® IBS Product Featured in Biotherapeutics Quarterly, a Henry Schein Publication, Highlighting a New Precision Approach for Treating IBS