Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study.
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.
Andriulli
Angelo
A
Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. a.andriulli@operapadrepio.it
Neri
Matteo
M
Loguercio
Carmelina
C
Terreni
Natalia
N
Merla
Antonio
A
Cardarella
Maria Pia
MP
Federico
Alessandro
A
Chilovi
Fausto
F
Milandri
Gian Luigi
GL
De Bona
Michela
M
Cavenati
Sergio
S
Gullini
Sergio
S
Abbiati
Roberto
R
Garbagna
Nicoletta
N
Cerutti
Renata
R
Grossi
Enzo
E
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
D009844:Oligosaccharides; D005973:Glutamine