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 approximately 60 weeks after the end of the original study.


RESULTS
A total of 25 patients entered the 2-week extension and 22 completed the approximately 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 >or=52-week follow-up, the rate of remissions was 81.5% to 100% (P < 0.003).


CONCLUSIONS
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 ( approximately 60-week) reductions in IBS symptoms.
Bittner
Alvah C
AC
Croffut
Robert M
RM
Stranahan
Mary C
MC
Yokelson
Titut N
TN
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003092:Colitis / Q000517:prevention & control; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004415:Dyspepsia / Q000517:prevention & control; D005260:Female; D005414:Flatulence / Q000517:prevention & control; D005500:Follow-Up Studies; D006801:Humans; D006812:Humic Substances / Q000009:adverse effects / Q000382:microbiology; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D006812:Humic Substances