TY - JOUR
T1 - Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome
T2 - a multicenter, randomized study.
AU - Andriulli, Angelo
AU - Neri, Matteo
AU - Loguercio, Carmelina
AU - Terreni, Natalia
AU - Merla, Antonio
AU - Cardarella, Maria Pia
AU - Federico, Alessandro
AU - Chilovi, Fausto
AU - Milandri, Gian Luigi
AU - De Bona, Michela
AU - Cavenati, Sergio
AU - Gullini, Sergio
AU - Abbiati, Roberto
AU - Garbagna, Nicoletta
AU - Cerutti, Renata
AU - Grossi, Enzo
PY - 2008/9
Y1 - 2008/9
N2 - 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.
AB - 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.
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M3 - Article
C2 - 18685503
AN - SCOPUS:58149137305
VL - 42 Suppl 3 Pt 2
JO - Journal of Clinical Gastroenterology
JF - Journal of Clinical Gastroenterology
SN - 0192-0790
ER -