Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with acute diarrhea: a multicenter, randomized study in primary care.
OBJECTIVE
Few randomized studies have been carried out on adult patients affected by acute diarrhea especially in primary care, which is the natural context for this kind of disorder. Lactobacillus paracasei B 21060 is a novel strain of lactobacillus, which has been shown to be effective in relieving symptoms associated with diarrhea of irritable bowel syndrome subtype and in shortening diarrhea duration. In this study, we compared the therapeutic efficacy, safety, and tolerability of a new symbiotic formulation, Flortec, containing L. paracasei B-21060, with lactobacillus GG (FlorVis GG) in the treatment of acute presumed infectious diarrhea.


METHODS
Fourteen general practitioners working in the Perugia health authority district carried out a randomized controlled, parallel-group, open trial in 174 adult patients suffering from acute diarrhea (87 enrolled in the Flortec group and 87 in the FlorVis group). Both the products were administered according to their standard recommended dosage. The main efficacy criterion was the duration of diarrhea after beginning treatment. Treatment duration was 10 days. Enrolled patients kept a careful track of their symptoms noting them in a personal diary for 12 days.


RESULTS
The 2 groups resulted to be homogeneous at baseline with regard to prognostic variables. The mean duration of diarrhea from the start of treatment in the Flortec group was 4.24 (2.73 SD) days versus 5.09 (3.72 SD) days in the FlorVis group (P=0.09).Clinical success rates in terms of absence of abdominal pain and absence of diarrhea (defined as <2 bowel movements of watery or loose stool consistency) recorded at different time-points were statistically superior in the Flortec group (Kaplan-Meyer P=0.05 for both the symptoms). The physician judged that overall efficacy was good or very good in 91.8% of the patients in the Flortec group. The corresponding value in the FlorVis group was 83.7% (P=0.003). The 2 treatments showed a very good tolerability profile, with negligible and similar adverse event rates and similar concomitant medication usage rates.


CONCLUSIONS
Oral therapy with Flortec proved to be more effective than FlorVis GG in the treatment of acute diarrhea in adults treated at a primary care setting.
Grossi
Enzo
E
Medical Department Bracco S.p.A, Milano, Italy. enzo.grossi@bracco.com
Buresta
Roberto
R
Abbiati
Roberto
R
Cerutti
Renata
R
D015746:Abdominal Pain / Q000382:microbiology / Q000628:therapy; D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003672:Defecation; D003967:Diarrhea / Q000382:microbiology / Q000503:physiopathology / Q000628:therapy*; D005243:Feces / Q000737:chemistry; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D007778:Lactobacillus / Q000254:growth & development*; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome