T2030 Evaluation of Lactobacillus Plantarum 299v Efficacy in IBS: Results of a Randomized Placebo-Controlled Trial in 200 Patients

Abstract

Introduction: Lactobacillus plantarum 299v is a probiotic strain indicated to treat IBS patients. No other trial so far has tested the symptomatic effect of this strain in such a large population sample. Aims & methods: The aim of this multicenter double blind randomized placebocontrolled trial was to determine the efficacy of L.plantarum 299v in a powerful trial. Patients from 19 to 70 years old and suffering from chronic IBS according to Rome III criteria were recruited in 3 Indian centers. Treatment duration was 4 weeks long with per day one cap of placebo or one cap of 1010 cfu of L.plantarum 299v. Both frequency and intensity of abdominal pain, bloating, feeling of incomplete rectal evacuation and the number of stools were assessed by a VAS. The results are expressed as the percentage of improvement between baseline and the end of the treatment period. Overall patients' assessment was expressed on a 4-point rated scale. Significance analyses were made by using Chi-square or ANOVAR tests. Results: The ITT population comprised 200 patients and only 10 patients dropped out (PP population: 190). Neither the demographic characteristics nor the diet were different between the two treatment arms (see table 1). At the end of treatment, L.plantarum 299v improved significantly the symptoms both compared to baseline and to placebo (see table 2). Overall patients' assessment was significantly better in the L.plantarum 299v group compared to the placebo group (see table 2). Pulse and respiratory rates, blood pressure and internal temperature remained normal throughout the study without any significant changes in both arms. No side-effect was reported in both groups. Conclusion: A 4 weeks treatment with Lactobacillus plantarum 299v has shown to be very effective for the relief of symptoms, particularly abdominal pain and bloating in IBS patients fulfilling the Rome III criteria. Table 2: Clinical Evaluation and Patients' assessment