Abstract Title:

Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study.

Abstract Source:

J Clin Gastroenterol. 2008 Sep;42 Suppl 3 Pt 2:S218-23. PMID: 18685503

Abstract Author(s):

Angelo Andriulli, Matteo Neri, Carmelina Loguercio, Natalia Terreni, Antonio Merla, Maria Pia Cardarella, Alessandro Federico, Fausto Chilovi, Gian Luigi Milandri, Michela De Bona, Sergio Cavenati, Sergio Gullini, Roberto Abbiati, Nicoletta Garbagna, Renata Cerutti, Enzo Grossi


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.

Study Type : Human Study

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