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Clinical Trial on the Efficacy of a New Symbiotic Formulation, Flortec, in Patients With Irritable Bowel Syndrome: A Multicenter, Randomized Study

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

Journal of Clinical Gastroenterology: September 2008 - Volume 42 - Issue - p S218-S223
doi: 10.1097/MCG.0b013e31817fadd6
PRESENTATIONS

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.

*Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo

Division of Gastroenterology, University of Chieti

Division of Gastroenterology, Second University of Naples

§Division of Gastroenterology, Valduce Hospital, Como

Division of Gastroenterology, Bolzano Hospital

Division of Gastroenterology, M. Bufalini Hospital, Cesena

Division of Gastroenterology, S. Maria del Prato Hospital, Feltre

**Division of Gastroenterology, Treviglio Hospital

††Division of Gastroenterology, S. Anna Hospital, Ferrara

‡‡Medical Department Bracco S.p.A. Milano, Italy

Supported by the Bracco Co, Milan, Italy.

Conflict of Interest Declaration: 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, and Sergio Gullini have participated as investigators in the clinical study on Flortec sponsored by Bracco. Their institutions have received a research grant for this study.

Roberto Abbiati, Nicoletta Garbagna, Renata Cerutti, and Enzo Grossi are employees of Bracco Co. Milan, Italy.

Angelo Andriulli wrote the initial draft of the paper, and E. Grossi amended it and approved the final version of it. All other mentioned coauthors actively enrolled patients into the trial and approved the final version of the manuscript. R. Abbiati and N. Garbagna are Bracco' employees and acted as study coordinators. R. Cerutti did the statistical analysis of collected information.

Reprints: Angelo Andriulli, MD, Division of Gastroenterology, “Casa Sollievo della Sofferenza” Hospital, IRCCS, San Giovanni Rotondo, Italy (e-mail: a.andriulli@operapadrepio.it).

Received for publication April 19, 2008; accepted April 23, 2008

© 2008 Lippincott Williams & Wilkins, Inc.