First- and second-line Helicobacter pylori eradication with modified sequential therapy and modified levofloxacin-amoxicillin-based triple therapy.

BACKGROUND: Helicobacter pylori (H. pylori) treatment remains a challenge for physicians. Although highly effective, the standard sequential therapy fails in a certain number of patients. Moreover, the cure rate following a levofloxacin-amoxicillin second-line triple therapy seems to be decreasing. We tested the efficacy of modified 10-day sequential therapy, and an intensified levofloxacin-amoxicillin regimen as first- and second-line therapy respectively. METHODS: In this prospective, open label, multicenter, pilot study H. pylori-infected patients received a first-line modified 10-day sequential therapy regimen including rabeprazole 20 mg, and amoxicillin 1 g for the first 3 days, followed by rabeprazole 20 mg, clarithromycin 250 mg, and metronidazole 250 mg, for the remaining 7 days, all drugs given thrice daily. An 8-day therapy regimen with rabeprazole 20 mg, levofloxacin 250 mg, and amoxicillin 1 g, all thrice daily, was administered a second-line therapy. RESULTS: A total of 99 and 15 patients were enrolled for first- and second-line therapy. The eradication rates were 85.9% (95% CI 80-93) and 93.4% (95% CI 88-98) according to ITT and PP analyses following modified sequential therapy, and 60% (95% CI 35-86) and 64.3% (95% CI 39-89) following the intensified second-line therapy. CONCLUSION: A modified sequential 3- plus 7-day regimen with thrice daily drug administration failed to achieve very high eradication rate at ITT analysis. The intensified second-line regimen achieved disappointingly low eradication rate. Novel levofloxacin-free second-line therapies are urged in Italy.

Helicobacter pylori eradication: sequential therapy and Lactobacillus reuteri supplementation.

AIM: To evaluate the role of sequential therapy and Lactobacillus reuteri (L. reuteri) supplementation, in the eradication treatment of Helicobacter pylori (H. pylori). METHODS: H. pylori infection was diagnosed in 90 adult dyspeptic patients. Patients were excluded if previously treated for H. pylori infection or if they were taking a proton pump inhibitor (PPI), H2-receptor antagonist or antibiotics. Patients were assigned to receive one of the following therapies: (1) 7-d triple therapy (PPI plus clarithromycin and amoxicillin or metronidazole) plus L. reuteri supplementation during antibiotic treatment; (2) 7-d triple therapy plus L. reuteri supplementation after antibiotic treatment; (3) sequential regimen (5-d PPI plus amoxicillin therapy followed by a 5-d PPI, clarithromycin and tinidazole) plus L. reuteri supplementation during antibiotic treatment; and (4) sequential regimen plus L. reuteri supplementation after antibiotic treatment. Successful eradication therapy was defined as a negative urea breath test at least 4 wk following treatment. RESULTS: Ninety adult dyspeptic patients were enrolled, and 83 (30 male, 53 female; mean age 57 ± 13 years) completed the study. Nineteen patients were administered a 7-d triple treatment: 11 with L. reuteri supplementation during and 8 after therapy. Sixty-four patients were administered a sequential regimen: 32 with L. reuteri supplementation during and 32 after therapy. The eradication rate was significantly higher in the sequential group compared with the 7-d triple regimen (88% vs 63%, P = 0.01). No difference was found between two types of PPI. No difference in eradication rates was observed between patients submitted to L. reuteri supplementation during or after antibiotic treatment. Compliance with therapy was excellent in all patients. No difference in adverse effects was observed between the different antibiotic treatments and between patients submitted to L. reuteri supplementation during and after antibiotic treatment. There was a low incidence of adverse effects in all groups of patients with sequential therapy, probably due to the presence of the L. reuteri supplementation. CONCLUSION: The sequential treatment regimen achieved a significantly higher eradication rate of H. pylori compared with standard 7-d regimen. L. reuteri supplementation could reduce the frequency and the intensity of antibiotic-associated side-effects.

High-fibre diet and Lactobacillus paracasei B21060 in symptomatic uncomplicated diverticular disease.

AIM: To investigate in symptomatic uncomplicated diverticular disease the efficacy of symbiotics associated with a high-fibre diet on abdominal symptoms. METHODS: This study was a multicentre, 6-mo randomized, controlled, parallel-group intervention with a preceding 4-wk washout period. Consecutive outpatients with symptomatic uncomplicated diverticular disease, aged 40-80 years, evaluated in 4 Gastroenterology Units, were enrolled. Symptomatic uncomplicated diverticular disease patients were randomized to two treatment arms A or B. Treatment A (n = 24 patients) received 1 symbiotic sachet Flortec(©) (Lactobacillus paracasei B21060) once daily plus high-fibre diet for 6 mo. Treatment B (n = 21 patients) received high-fibre diet alone for 6 mo. The primary endpoint was regression of abdominal symptoms and change of symptom severity after 3 and 6 mo of treatment. RESULTS: In group A, the proportion of patients with abdominal pain < 24 h decreased from 100% at baseline to 35% and 25% after 3 and 6 mo, respectively (P < 0.001). In group B the proportion of patients with this symptom decreased from 90.5% at baseline to 61.9% and 38.1% after 3 and 6 mo, respectively (P = 0.001). Symptom improvement became statistically significant at 3 and 6 mo in group A and B, respectively.The proportion of patients with abdominal pain >24 h decreased from 60% to 20% then 5% after 3 and 6 mo, respectively in group A (P < 0.001) and from 33.3% to 9.5% at both 3 and 6 mo in group B (P = 0.03). In group A the proportion of patients with abdominal bloating significantly decreased from 95% to 60% after 3 mo, and remained stable (65%) at 6-mo follow-up (P = 0.005) while in group B, no significant changes in abdominal bloating was observed (P = 0.11). After 6 mo of treatment, the mean visual analogic scale (VAS) values of both short-lasting abdominal pain (VAS, mean ± SD, group A: 4.6 ± 2.1 vs 2.2 ± 0.8, P = 0.02; group B: 4.6 ± 2.9 vs 2.0 ± 1.9, P = 0.03) and abdominal bloating (VAS, mean ± SD, group A: 5.3 ± 2.2 vs 3.0 ± 1.7, P = 0.005; group B: 5.3 ± 3.2 vs 2.3 ± 1.9, P = 0.006) decreased in both groups, whilst the VAS values of prolonged abdominal pain decreased in the Flortec(©) group, but remained unchanged in the high-fibre diet group (VAS, mean ± SD, group A: 6.5 ± 1.5 vs 4.5 ± 2.1, P = 0.052; group B: 4.5 ± 3.8 vs 5.5 ± 3.5). CONCLUSION: A high-fibre diet is effective in relieving abdominal symptoms in symptomatic uncomplicated diverticular disease. This treatment may be implemented by combining the high-fibre diet with Flortec(©).