Prescript-assist™ probiotic-prebiotic treatment for irritable bowel syndrome: An open-label, partially controlled, 1-year extension of a previously published controlled clinical trial

Objective:The aim of this study was to extend a previous 2-week assessment of a probiotic-prebiotic complex in patients with irritable bowel syndrome (IBS).Methods:In this open-label, partially controlled, 1-year (14 [2] months) extension study, data were collected from patients with IBS who continued treatment following a 2-week study of the efficacy of the probiotic-prebiotic complex. Data were collected at 2 and ∼60 weeks after the end of the original study.Results:A total of 25 patients entered the 2-week extension and 22 completed the ∼60-week follow-up study (20 women, 2 men; age range, 20–70 years; all white). Results in the control group 2 weeks after crossover to treatment were similar to those from the original study, with reductions in IBS subsyndromes, as follows: general ill feelings/nausea (P < 0.001), indigestion/flatulence (P < 0.001), and marginally colitis (P < 0.03 [1-tailed]). Treatment was associated with a continued reduction in general ill feelings/nausea at 4 weeks (P < 0.007). At ≥52-week follow-up, the rate of remissions was 81.5% to 100% (P < 0.003).Conclusion:Based on the results from the present 1-year extension study, treatment with this probiotic-prebiotic complex may be an option for short-term (2–4 weeks) and long-term (∼60-week) reductions in IBS symptoms.