Lactobacillus reuteri in management of Helicobacter pylori infection in dyspeptic patients: a double-blind placebo-controlled randomized clinical trial

Abstract

Introduction: The eradication rate of Helicobacter pylori following the standard triple therapy is declining. This study was conducted to test whether the addition of Lactobacillus reuteri to the standard triple therapy improves the eradication rates as well as the clinical and pathological aspects in H. pylori infection.

Methods: A total of 70 treatment-naïve patients were randomly assigned into group A (the L. reuteri treated group) and group B (the placebo control group). Patients were treated by the standard triple therapy for 2 weeks and either L. reuteri or placebo for 4 weeks. They were examined by symptom questionnaire, H. pylori antigen in stool, upper endoscopy with biopsies for rapid urease test and histopathological examination before treatment and 4 weeks after treatment.

Results: The eradication rate of H. pylori infection was 74.3% and 65.7% for both L. reuteri and placebo treated groups, respectively. There was a significant difference regarding the reported side effects, where patients treated with L. reuteri reported less diarrhea and taste disorders than placebo group. A significant difference within each group was observed after treatment regarding Gastrointestinal Symptom Rating Scale (GSRS) scores; patients treated with L. reuteri showed more improvement of gastrointestinal symptoms than the placebo treated group. The severity and activity of H. pylori associated gastritis were reduced after 4 weeks of therapy in both groups. The L. reuteri treated group showed significant improvement compared with the placebo treated group.

Conclusion: Triple therapy of H. pylori supplemented with L. reuteri increased eradication rate by 8.6%, improved the GSRS score, reduced the reported side effects and improved the histological features of H. pylori infection when compared with placebo-supplemented triple therapy.

Keywords: Gastrointestinal Symptom Rating Scale; Helicobacter pylori; Lactobacillus reuteri; eradication rate; gastritis; triple therapy.

Conflict of interest statement

Conflict of interest statement: The authors declare no conflicts of interest in preparing this article.

Figures

Figure 1.

Study flow chart. Out of 213 patients, 94 patients met the inclusion criteria of whom 70 were randomly assigned to the L. reuteri and placebo groups. HpSA, H. pylori stool antigen; RUT, rapid urease test; Endo, endoscopic; histo, histopathological confirmation; GSRS, Gastrointestinal Symptom Rating Scale; Ome, omeprazole; Amox, amoxicillin; Clarith, clarithromycin; bid, twice daily; w, week.

Figure 2.

Gastrointestinal Symptom Rating Scale (GSRS) values between both groups at baseline and 8 weeks later and between each group before and 4 weeks after end of treatment. ns, not significant.

Figure 3.

Inflammatory cell score (lymphocytes, plasma cells) between both groups at baseline and 8 weeks later and between each group before and 4 weeks after end of treatment.

Figure 4.

Inflammatory cell score (neutrophils) between both groups at baseline and 8 weeks later and between each group before and 4 weeks after end of treatment.