4.3 Article

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

Journal

CLINICAL THERAPEUTICS
Volume 29, Issue 6, Pages 1153-1160

Publisher

ELSEVIER
DOI: 10.1016/j.clinthera.2007.06.010

Keywords

irritable bowel syndrome; subsyndromes; 12-month follow-up; probiotic; prebiotic; efficacy

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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 problotic-preblotic complex. Data were collected at 2 and similar to 60 weeks after the end of the original study. Results: A total of 25 patients entered the 2-week extension and 22 completed the similar to 60-week followup 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 problotic-prebiotic complex may be an option for short-term (2-4 weeks) and long-term (similar to 60-week) reductions in IBS symptoms.

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