Methods: In 2 Phase 3 IBS-C trials, patients meeting Rome II IBS-C criteria received once-daily 290-μg linaclotide or placebo. Patients reported daily abdominal pain, discomfort, bloating, fullness, cramping, spontaneous bowel movement [SBM] and complete SBM [CSBM] frequency, stool consistency, and straining. AR of IBS-C symptoms was reported weekly (yes/no). CMC thresholds for these symptoms were estimated using receiver-operating-characteristic methods with AR as an anchor (pooled 12-week trial data). Linaclotide/placebo results were compared using these thresholds to define 12-week responders.

Distribution of agreement between weekly AR and FDA responder criteria (≥30% reduction in worst abdominal pain and increase in CSBMs of ≥1 from baseline) was assessed. Results: AR-based CMC thresholds for abdominal symptom percent improvement from baseline Ganetespib mw ranged from 21.9–33.6%, while change-from-baseline thresholds for improvement in SBMs and CSBMs/week were 2.1 and 0.7, respectively. Responder rates for AR and FDA criteria were

greater in linaclotide vs placebo groups. Analysis of weekly responder rates revealed considerable agreement (≥70%) between AR and FDA responder EPs. These binary responses were reflected by greater rates of clinically meaningful improvement for all abdominal/bowel symptoms for linaclotide NVP-BKM120 solubility dmso vs placebo (all endpoints P < .001). Numbers needed to treat ranged from 5.1–6.4 for abdominal symptoms and 2.4–3.7 for bowel symptoms. Conclusion: Responder analyses based on CMC

thresholds estimated using AR indicated that linaclotide resulted in a higher percentage of patients experiencing clinically meaningful improvement in IBS-C symptoms vs placebo. There was considerable agreement between AR and FDA responder endpoints. Key Word(s): 1. IBS-C; 2. linaclotide; 3. abdominal symptoms; 4. relief; Presenting Author: JOSEISIDRO MINERO Additional Authors: EIRA Edoxaban CERDA Corresponding Author: JOSEISIDRO MINERO Affiliations: HCM Objective: Background. The small intestinal bacterial overgrowth (SIBO) has been considered part of the pathophysiology of irritable bowel syndrome and treatment with rifaximin 400 mg orally every 8 hours for 10 days have been proposed, since it decreased SIBO by 80%. The need of retreatment and the time lapse of it have not been established. Purpose: To determine the time lapse of retreatment with rifaximin in patients with SIBO, evaluated with Global Symptom Scale (GSS), Bristol Scale (BS) and glucose breath test. Methods: Material and Methods: SIBO patients (H breath test positive) that have been treated with rifaximin 400 mg every 8 hours for 10 days were followed for one year, GSS and BS were fulfilled at 6 and 12 months and glucose hydrogen breath tests were performed at 12 months. Patients with relapsing symptoms were treated again with rifaximin 400 mg every 8 hours for 10 days. Results: Results. We evaluated 10 patients.