Characteristics of a Prospectively Collected Patient Sample Set Used in the Development of a Blood-Based Diagnostic for Irritable Bowel Syndrome (IBS)

Purpose: To support the development and validation of a blood-based diagnostic for IBS, samples and medical histories were collected from a large cohort of well-characterized patients with functional and organic gastrointestinal diseases and from healthy control subjects. Methods: A prospective study for sample collection was conducted in patients 18 years and older with IBS, other functional diseases, inflammatory bowel disease (IBD) or celiac disease, all with major co-morbidities excluded. Inclusion and exclusion criteria were established with input from experts in the disease fields. IRB approval and informed consents were obtained. All patients with IBS or functional disease met the Rome III criteria and had a diagnosis of disease without alarm signs for at least one year. Diagnosis of IBD and celiac disease were made by standard of care and were confirmed by endoscopy and biopsy. Extensive medical histories were collected and patients were administered modules of the Rome III questionnaire and a somatization questionnaire. Additionally, patients were asked how frequently the disease impacted their life. Serum samples were collected and shipped to Prometheus Laboratories for analysis and development of the diagnostic. Results: This study yielded samples from 1335 subjects from 45 experienced gastroenterology research clinics throughout the U.S. Disease distribution and demographic data for the samples are shown in columns 2 to 4 of the table below. The percent of patient responding that their disease impacted their life greater than 50% of the time is shown in column 5. The percent of subjects reporting a formal diagnosis of IBS of a parent or sibling is shown in column 6. Conclusion: Well characterized samples were collected in a prospective study for the development and validation of a blood-based IBS diagnostic. Mean age of the patients was in the mid to late 40's. Of the patients in this study, those with IBS (diarrhea and mixed) and functional diarrhea seemed to report a greater impact on their daily life. Approximately 15–20% of the IBS patients reported a family history of IBS. The demographics of samples collected are consistent with other IBS clinical studies. Further characterization and analyses will be performed on the study data.Table