Luca Santarelli

Effect of different probiotic preparations on anti-helicobacter pylori therapy-related side effects: a parallel group, triple blind, placebo-controlled study

OBJECTIVES: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.i.d., 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.

Efficacy of two one-week rabeprazole/levofloxacin-based triple therapies for Helicobacter pylori infection.

One‐week low‐dose proton pump inhibitor‐based triple therapies have usually proved to be effective treatments for Helicobacter pylori infection.

Effect of Lactobacillus GG Supplementation on Antibiotic-Associated Gastrointestinal Side Effects during Helicobacter pylori Eradication Therapy: A Pilot Study

Background: One-week triple therapy is currently regarded as the reference of anti-Helicobacter pylori treatment. However, antibiotic-associated gastrointestinal side effects are among the major pitfalls of such regimens. Probiotic supplementation may be regarded as a therapeutic tool to prevent or reduce these troublesome drug-related manifestations. Aim: To determine whether the addition of the probiotic Lactobacillus GG to an anti-H. pylori standard triple therapy could help to prevent or minimize the occurrence of gastrointestinal side effects. Methods: One hundred and twenty healthy asymptomatic subjects screened positive for H. pylori infection and deciding to receive eradication therapy were randomized either to 1-week pantoprazole (40 mg b.i.d.), clarithromycin (500 mg b.i.d.), tinidazole (500 mg b.i.d.) or to the same regimen supplemented with Lactobacillus GG for 14 days. Patients filled in validated questionnaires during follow-up to determine the type and severity of side effects and to judge overall tolerability. Results: Bloating, diarrhea and taste disturbances were the most frequent side effects during the eradication week and were significantly reduced in the Lactobacillus GG-supplemented group (RR = 0.4, CI 0.2–0.8; RR = 0.3, CI 0.1–0.8; RR = 0.3, CI 0.1–0.7, respectively). The same pattern was observed throughout the follow-up period. Overall assessment of treatment tolerability showed a significant trend in favor of the Lactobacillus GG-supplemented group (p = 0.03). Conclusions:Lactobacillus GG supplementation beneficially affects H. pylori therapy-related side effects and overall treatment tolerance.

Levofloxacin-based triple therapy vs. quadruple therapy in second-line Helicobacter pylori treatment: a randomized trial

Background : Levofloxacin has been shown to be effective in Helicobacter pylori eradication. Two 10‐day levofloxacin‐based triple therapies were compared with standard 7‐ and 14‐day quadruple regimens in second‐line treatment.

Levofloxacin based regimens for the eradication of Helicobacter pylori.

Background A 7 day treatment scheme based on rabeprazole/levofloxacin/amoxycillin or tinidazole achieved an eradication rate over 90%. However, the combination of drugs and duration of treatment for the correct use of levofloxacin in the eradication of Helicaobacter pylori are still unclear. Objective To compare the efficacy and tolerability of rabeprazole/levofloxacin based dual therapies given for 5, 7 or 10 days with rabeprazole/levofloxacin/amoxycillin triple therapy for 7 days. Methods One hundred and sixty patients with H. pylori infection documented by the 13C-urea breath test and histology were included in this prospective, open label study. Subjects were randomized in four groups: (1) levofloxacin (500 mg o.d.), amoxycillin (1 g b.d.) and rabeprazole (20 mg o.d.) for 7 days; (2) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 5 days; (3) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 7 days; and (4) levofloxacin (500 mg o.d.) and rabeprazole (20 mg o.d.) for 10 days. Six weeks after the end of therapy H. pylori status was checked by using the 13C-urea breath test. Results All patients completed the therapeutic regimens. The eradication rate was not significantly modified by treatment duration in the dual therapy schemes (5 days: 20/40, 50%; 7 days: 28/40, 70%; 10 days: 26/40, 65%). The eradication rate of the 1 week levofloxacin based triple therapy was significantly higher than that observed using any dual therapies (36/40). No major adverse effects were observed. Conclusions A rabeprazole/levofloxacin dual eradication regimen is simple and well tolerated but does not achieve an acceptable eradication rate when compared to a 1 week rabeprazole/levofloxacin/amoxycillin triple therapy. The eradication rate did not increase with a longer regimen.

Probiotics and Helicobacter pylori eradication.

The need for new strategies for Helicobacter pylori eradication, alternative or complementary to antibiotic therapy, has recently claimed the attention of many investigators. Pre-clinical studies have shown the inhibition of Helicobacter pylori growth by Lactobacilli and the anti-Helicobacter pylori action of Lactobacillus salivarius, Lactobacillus acidophilus and Lactobacillus casei subspecies rhamnosus strains, possibly due to the production of lactic acid or to the secretion of an autolysin. Clinical studies have demonstrated a persistent reduction in delta over baseline values at the 13C urea breath test independently of omeprazole administration with Lactobacillus acidophilus La1, the eradication in 6 out of 14 patients with Lactobacillus acidophilus alone, positive results in patients in which a standard Helicobacter pylori triple therapy was randomly supplemented with Lactobacillus acidophilus.

Probiotics in antibiotic-associated diarrhoea

Antibiotic-associated diarrhoea is a common event. In some cases, it could represent a life-threatening event. Clostridium difficile colitis is a further distinct complication of antibiotic administration. Treatment options for antibiotic-associated diarrhoea and Clostridium difficile colitis include supplementation with several types of probiotics, as overviewed in this paper. Three randomised, double-blind, controlled clinical trials show a therapeutic effect of Saccharomyces boulardii in antibiotic-associated diarrhoea. The efficacy of Lactobacillus acidophilus and bulgaricus has also been ascertained in two double-blind controlled studies. Other studies focusing on Lactobacillus as a new preventive agent for antibiotic-associated diarrhoea are not double-blind. Among these, a positive effect of Lactobacillus rhamnosus GG, Bifidobacterium longum and Enterococcus faecium SF68 has been reported. Effectiveness of probiotics in antibiotic-associated diarrhoea has, therefore, a consistent scientific rationale, however few studies have performed an assessment of bacterial recovery in stools, and this approach may be helpful in deciding a more rigorous dose standardisation.

Atrophic gastritis as a cause of hyperhomocysteinaemia.

Background : Hyperhomocysteinaemia is an independent risk factor for atherosclerosis. It is often related to low levels of vitamin B12 and/or folate, enzymatic co‐factors of methionine metabolism. Atrophic gastritis, often caused by Helicobacter pylori infection, may impair vitamin absorption.

Link between Helicobacter pylori infection and iron-deficiency anaemia in patients with coeliac disease.

Background: Iron-deficiency anaemia is a frequent finding in coeliac disease. Recent investigations have identified Helicobacter pylori infection as a factor responsible for iron deficiency. We investigated the potential relationship between H. pylori and iron-deficiency anaemia in patients with coeliac disease. Methods: We conducted a prospective observational cohort study on coeliac patients evaluated for irondeficiency anaemia. An upper gastrointestinal endoscopy was performed and biopsy specimens of duodenal and gastric mucosa were taken for histological examination and assessment of Helicobacter pylori status. Results: The initial database was 386 subjects. Of these, 24 were excluded because of concomitant potential causes of iron deficiency. Of the 362 enrolled patients, H. pylori was detected in 77 (21%) subjects; of these 55 (71%) had iron-deficiency anaemia. Among the 285 H. pylori -negative subjects, 81 (28%) showed anaemia ( P < 0.001). We did not find significant differences in gastric histolo...Background: Iron-deficiency anaemia is a frequent finding in coeliac disease. Recent investigations have identified Helicobacter pylori infection as a factor responsible for iron deficiency. We investigated the potential relationship between H. pylori and iron-deficiency anaemia in patients with coeliac disease. Methods: We conducted a prospective observational cohort study on coeliac patients evaluated for irondeficiency anaemia. An upper gastrointestinal endoscopy was performed and biopsy specimens of duodenal and gastric mucosa were taken for histological examination and assessment of Helicobacter pylori status. Results: The initial database was 386 subjects. Of these, 24 were excluded because of concomitant potential causes of iron deficiency. Of the 362 enrolled patients, H. pylori was detected in 77 (21%) subjects; of these 55 (71%) had iron-deficiency anaemia. Among the 285 H. pylori -negative subjects, 81 (28%) showed anaemia ( P < 0.001). We did not find significant differences in gastric histological aspects between patients with or without iron deficiency anaemia. Conclusions: This study shows a significant association between H. pylori infection and iron-deficiency anaemia in patients with coeliac disease. The discovery of iron-deficiency anaemia in coeliac subjects may constitute another indication for the diagnosis and treatment of this worldwide infection.

Helicobacter pylori Treatment: A Role for Probiotics?

Many new therapeutic strategies are studied to improve Helicobacter pylori eradication rate. Probiotics are live microorganisms which, upon administration, may interact with the human microflora and positively affect the health status. The use of probiotics in the field of H. pylori infection has been proposed for improving eradication rate and tolerability and for compliance of multiple antibiotic regimens used for the infection. Results from laboratory studies and from clinical trials seem to confirm the expectancies, but there is lack of standardization in terms of type of probiotic strain used, dosage and timing of supplementation. Before further ongoing trials and future studies will clarify these points, probiotics could remain a useful adjunct to standard anti-H. pylori therapies, but cannot take the place of other validated options.