Abstract
Purpose: Recently, there has been growing interest in the use of probiotics to ameliorate various digestive symptoms. The majority of studies in this field have focused on the effect of probiotics on lower gastrointestinal (GI) symptoms. Upper GI and postprandial symptoms are common functional GI complaints, and possess a significant impact on patient well-being and quality of life. However, there is no data on the effect of probiotics on upper GI, and specifically on postprandial GI symptoms. Aim: To investigate the effect of probiotics on common postprandial symptoms in subjects with functional GI disorders using two probiotic products previously shown to be beneficial in alleviating lower functional GI symptoms. Methods: Subjects who participated in two separate probiotic clinical trials were evaluated for the effect of the intervention on their postprandial and eating associated symptoms. The intervention included 5x109 cfu total Bifidobacterium animalis lactis Bb12 (BB12) and 1.0g inulin per day for six weeks (Study 1) or Lactobacillus acidophilus (L-NCFM) and Bifidobacterium lactis Bi-07 1x1011 cfu total per day for eight weeks (Study 2). Postprandial symptoms were assessed using a specific questionnaire designed to capture information about the frequency, characteristics, and severity of postprandial symptoms. The severity of each symptom was assessed on a 5-point likart scale. Pre- to mid- and pre- to post-intervention changes in frequency and severity of postprandial symptoms for each probiotic intervention vs. placebo were assessed using a two-sided t test with a significance level of p<0.05. Results: A total of 117 (probiotic n=30, placebo n=30 in Study 1 and probiotic n=30, placebo n=27 in Study 2) patients were enrolled. Study population consisted of 72% females, 84% whites, and a mean age of 37 years. Baseline demographics were similar between the two groups in both studies. No significant pre- to -post changes in the frequency or severity of symptoms were noted in either probiotic intervention compared to placebo, despite significant clinical benefits on lower GI symptoms (overall well being in study 1 and bloating in study 2); and an observed beneficial effect on GI physiology (reduced colonic transit time) in Study 1. Conclusion: Although negative, these results are important in directing clinicians and patients in regard to expected beneficial effects of these probiotic interventions. Our study results further emphasize that the effect of probiotics is product and symptom specific. Disclosure: Dr Ringel- Grant/Research Support from Danisco and General Mills, Inc. This research was supported by an industry grant from Danisco; General Mills Inc.
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