Quadruple therapy with lactoferrin for Helicobacter pylori eradication: A randomised, multicentre study

Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment. Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1 g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200 mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by 13C urea breath test 4–6 weeks after treatment. H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68–88) and in 53/66 (80.3%; 95% CI = 71–89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67–87) and 50/64 (78.1%; 95% CI = 68–88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT ( p = 0.9) and PP analyses ( p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively ( p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects. Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin–amoxycillin based triple therapy in non-ulcer dyspepsia patients.