title: Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. a.andriulli@operapadrepio.it
authors.forename: Angelo
authors.initials: A
authors.lastname: Andriulli
authors.forename: Matteo
authors.initials: M
authors.lastname: Neri
authors.forename: Carmelina
authors.initials: C
authors.lastname: Loguercio
authors.forename: Natalia
authors.initials: N
authors.lastname: Terreni
authors.forename: Antonio
authors.initials: A
authors.lastname: Merla
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Cardarella
authors.forename: Alessandro
authors.initials: A
authors.lastname: Federico
authors.forename: Fausto
authors.initials: F
authors.lastname: Chilovi
authors.forename: Gian Luigi
authors.initials: GL
authors.lastname: Milandri
authors.forename: Michela
authors.initials: M
authors.lastname: De Bona
authors.forename: Sergio
authors.initials: S
authors.lastname: Cavenati
authors.forename: Sergio
authors.initials: S
authors.lastname: Gullini
authors.forename: Roberto
authors.initials: R
authors.lastname: Abbiati
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Garbagna
authors.forename: Renata
authors.initials: R
authors.lastname: Cerutti
authors.forename: Enzo
authors.initials: E
authors.lastname: Grossi
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D005973:Glutamine / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000503:physiopathology / Q000628:therapy*; D007778:Lactobacillus; D008297:Male; D008875:Middle Aged; D009844:Oligosaccharides / Q000008:administration & dosage / Q000627:therapeutic use; D019936:Probiotics / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D009844:Oligosaccharides; D005973:Glutamine