Effect of different probiotic preparations on anti-helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study.
OBJECTIVE
Several studies show that probiotics may prevent side effects during therapy against Helicobacter pylori (H. pylori). Other reports indicate competitive interaction between some probiotics and H. pylori. We compared efficacy of two different probiotics and one probiotic combination with placebo for preventing anti-H. pylori therapy-related side effects and for improving the eradication rate.


METHODS
A total of 85 H. pylori positive, asymptomatic patients were randomized in four groups to receive probiotic or placebo both during and for 7 days after a 1-wk triple therapy scheme (rabeprazole 20 mg b.id., clarithromycin 500 mg b.i.d., and tinidazole 500 mg b.i.d.). Group I (n = 21) received Lactobacillus GG; group II (n = 22), Saccharomyces boulardii; group III (n = 21), a combination of Lactobacillus spp. and biphidobacteria; and group IV (n = 21), placebo. Subjects filled in weekly symptom questionnaires for 4 wk. Blinded investigators collected and analyzed data. H. pylori status was rechecked after 5-7 wk.


RESULTS
Side effects occurred mainly during the eradication week. None of them caused therapy discontinuation. In all probiotic-supplemented groups, there was a significantly lower incidence of diarrhea and taste disturbance during the eradication week with respect to the placebo group. Overall assessment of tolerability was significantly better in the actively treated patients than in the placebo group. No differences in the incidence of side effects between the probiotic groups were observed. The H. pylori eradication rate was almost identical between the probiotic and placebo groups.


CONCLUSIONS
All the probiotics used were superior to placebo for side effect prevention, but were not associated with better compliance with antibiotic therapy. The effect of probiotic supplementation on side effects during anti-H. pylori regimens seemed to be independent of the probiotic species used.
Cremonini
Filippo
F
Department of Internal Medicine, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Roma, Italy.
Di Caro
Simona
S
Covino
Marcello
M
Armuzzi
Alessandro
A
Gabrielli
Maurizio
M
Santarelli
Luca
L
Nista
Enrico C
EC
Cammarota
Giovanni
G
Gasbarrini
Giovanni
G
Gasbarrini
Antonio
A
D015746:Abdominal Pain / Q000139:chemically induced / Q000517:prevention & control; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003248:Constipation / Q000139:chemically induced / Q000517:prevention & control; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control; D004311:Double-Blind Method; D001068:Feeding and Eating Disorders / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D005414:Flatulence / Q000139:chemically induced / Q000517:prevention & control; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D019936:Probiotics / Q000008:administration & dosage* / Q000494:pharmacology*; D013651:Taste Disorders / Q000139:chemically induced / Q000517:prevention & control; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
D000900:Anti-Bacterial Agents