Professor of Medicine, UNC Charlotte Atrium Health, University of North Carolina Charlotte, NC
Baharak Moshiree, MD, MSc1, Abraham Khan, MD2, Mitchell L. Jones, MD, PhD3, Sharat Singh, PhD3, Christopher Wahl4, Emil Chuang, MD3; 1Atrium Health, University of North Carolina, Charlotte, NC; 2New York University Langone Medical Center, New York, NY; 3Progenity Inc., San Diego, CA; 4Progenity, San Diego, CA
Introduction: Small intestinal bacterial overgrowth (SIBO) has clinical overlap with irritable bowel syndrome (IBS) and is diagnosed either by endoscopic small bowel aspiration (SBA) with quantitative bacterial culture or hydrogen breath testing (BT). SBA is invasive and lacks standardization and BT has questionable accuracy and unreliable performance.
Methods: Qualitative phone interviews with 7 GIs/3 IBS experts explored unmet needs in SIBO diagnosis and gathered feedback on a novel smart capsule bacterial detection system (SCBDS) _ an ingestible capsule with an integrated assay for wirelessly determining small intestinal total bacterial count based on an FDA-approved threshold of ≥105 CFU/ml. A quantitative online survey of 28 academic and 62 community GIs assessed practice patterns and preferred clinical characteristics of SCBDS.
Results: GIs saw 77 IBS and 22 SIBO patients on average per month. Suspected SIBO patients (36%) were formally diagnosed by BT with academic GIs placing a greater importance on a formal diagnosis rather than empiric antibiotic therapy. 10% of practices performed SBA for SIBO diagnosis. (Fig. 1) SIBO diagnosis was evaluated by BT in 47% of patients with only a fraction of GIs giving high ratings for BT accuracy. Empiric antibiotic therapy was performed in ~50% of suspected SIBO patients across both settings, but 91% were at least somewhat concerned with this practice and 60% were unsatisfied with all current diagnostic options. (Fig. 2) Insufficient accuracy was the most frequently selected diagnostic unmet need, with 58% of GIs selecting it as one of the greatest unmet needs, followed by difficulty in interpreting results (48%). (Fig. 3) Over 70% of GIs indicated that SCBDS would be more accurate than BT and would recommend it to almost two-thirds of patients evaluated for SIBO and to one-third for IBS. Two-thirds of GIs also anticipated using SCBDS first over empiric antibiotic therapy alone. In addition, 59% of BT users and 66% performing SBA would replace these methods with SCBDS.
Discussion: GIs in both community and academic settings expressed a significant unmet need in SIBO diagnosis driven by BT performance limitations, and only a small minority of GIs were performing SBA to diagnose SIBO. A perceived strength of an FDA-approved SCBDS would be improved accuracy, interpretation and precision as compared to BT, with the majority of GIs suggesting they would replace conventional SIBO diagnostics with such a technology.
Fig 1: Patient workup for suspected of SIBO vs IBS.
Fig 2: Gastroenterologists satisfaction with currently available options to diagnose SIBO.
Fig 3: Gastroenterologists current perception of unmet medical need for diagnosing SIBO.
Disclosures: Baharak Moshiree: Progenity – Advisory Committee/Board Member. Progenity – Advisory Committee/Board Member, Consultant. Abraham Khan: Progenity – Consultant. Mitchell Jones: Progenity – Employee. Sharat Singh: Progenity – Employee. Christopher Wahl: Progenity Inc. – Employee. Emil Chuang: Progenity – Employee.