J Clin Gastroenterol. 2008 Aug 5. [Epub ahead of print]
Clinical Trial on the Efficacy of a New Symbiotic Formulation, Flortec, in Patients With Irritable Bowel Syndrome: A Multicenter, Randomized Study.
Andriulli A, Neri M, Loguercio C, Terreni N, Merla A, Cardarella MP, Federico A, Chilovi F, Milandri GL, De Bona M, Cavenati S, Gullini S, Abbiati R, Garbagna N, Cerutti R, Grossi E. Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo daggerDivision of Gastroenterology, University of Chieti double daggerDivision of Gastroenterology, Second University of Naples section signDivision of Gastroenterology, Valduce Hospital, Como parallelDivision of Gastroenterology, Bolzano Hospital paragraph signDivision of Gastroenterology, M. Bufalini Hospital, Cesena musical sharpDivision of Gastroenterology, S. Maria del Prato Hospital, Feltre **Division of Gastroenterology, Treviglio Hospital daggerdaggerDivision of Gastroenterology, S. Anna Hospital, Ferrara double daggerdouble daggerMedical Department Bracco S.p.A. Milano, Italy.
OBJECTIVES: Efficacy of symbiotics in patients with irritable bowel syndrome (IBS) remains unknown.
METHODS: Patients were randomized to a prebiotic (n=135), or a symbiotic formulation containing Lactobacillus paracasei B21060 (Flortec, n=132). Primary efficacy was the responder rate for pain and global relief of symptoms in the overall population and in patients with predominant diarrhea (n=47). Post hoc time-trend analyses for changes within each treatment were carried out.
RESULTS: Patients with absent/mild pain amounted to 54.7% in the symbiotic group and to 57.4% in the prebiotic group at treatment week 4, and to 53.9% and 53.4% at the end of treatment. Patients with amelioration of well-being were, respectively, 60.7% versus 61.7% at treatment week 4, and 63.3% versus 60.9% at the end of treatment. Within each treatment group, patients with absent/mild pain increased in the Flortec and the prebiotic group, but time trend analyses were significant only for Flortec (P=0.019). In IBS-predominant diarrhea, Flortec significantly reduced bowel movements, pain, and IBS scores.
CONCLUSIONS: To improve pain and well-being, Flortec is encouraging in patients with diarrhea predominant IBS. To establish its efficacy for the majority of IBS patients, Flortec has to be compared with an inert placebo in future work.
PMID: 18685503 [PubMed - as supplied by publisher]