Available online 10 November 2022
AbstractBackground and study aimsThe aim of this study was to evaluate the efficacy of probiotic as an adjuvant in quadruple therapy for H. pylori eradication compared with placebo.
Patients and methodsThis randomized, double-blind, controlled trial was conducted on 450 patients with confirmed H. pylori infection. We randomly allocated patients (1:1) to receive probiotic (Lactobacillus ruteri, 100 mg) or placebo as an adjuvant in quadruple therapy with bismuth subcitrate 240 mg, pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg all twice daily for 14 days. The primary outcome of the study was the H. pylori eradication rate at eight weeks after the end of treatment using 14C-urea breath test. The secondary endpoint of study was patient-reported side effects of drugs. The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20080901001155N32).
ResultsH. pylori eradication rates were higher in the probiotic group, compared to placebo, but this difference was not statistically significant, according to both intention-to-treat (78.7 % (95 % CI; 71.24–86.16) versus 72 % (95 % CI; 64.9–79.1), respectively) and per-protocol (80.1 % (95 % CI; 73.7 – 86.5) versus 75.2 %(95 % CI; 68.4 – 82), respectively). About 69.7 % of patients in the probiotic group experience side effects compared to 98.6 % in the placebo group that was statistically significant (P-value < 0.001). Headache and all gastrointestinal adverse events except constipation were significantly lower in the probiotic group compared to placebo (P-value < 0.001).
ConclusionAdding Lactobacillus ruteri to quadruple therapy did not significantly improve the eradication of H. pylori. However it reduced the frequency of drug-associated side effects.
Section snippetsIntroduction:Helicobacter pylori (H. pylori) has infected about half of the world's population [1]. This pathogen is the main risk factor for peptic ulcer disease [2] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma [3].
Several eradication regimens have been suggested for treatment of H. pylori The most common regimens recommended as first-line treatment include triple therapy (proton pump inhibitor plus two antibiotics) and quadruple therapy (bismuth and proton pump inhibitor plus two
Study design and participants:The present study is a phase 3 randomized clinical trial. This double-blind randomized controlled trial compared two parallel groups of patients referred to clinics of Caspian Digestive Disease Research Center and Gastrointestinal and Liver Disease Research Center (Northern Province of Iran) for endoscopy, from December 2019 through September 2020. The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20080901001155N32). Written informed consent was obtained from each
ResultsOf the 450 patients who were recruited in the study and were randomly allocated to receive placebo and lactobacillus ruteri, 431(95.7 %) were included in the final PP analysis (Fig. 1). Twenty-nine patients were excluded from final PP analysis for non-compliance (14 in assigned to lactobacillus ruteri, 15 in placebo).
Baseline characteristics of patients are presented in Table 1. Clinical and demographic characteristics were well matched in two groups according to both ITT and PP analyses. The
DiscussionThe findings of this double-blind randomized controlled trial suggest that, although Lactobacillus ruteri as an adjuvant of H. pylori eradication quadruple therapy (bismuth subcitrate, pantoprazole, amoxicillin and clarithromycin for 14 days) lead to higher eradication rate compared to placebo, but this difference was not statistically significant. Our results are consistent with a systematic review that demonstrated additional probiotic treatment did not improve the eradication rate [11].
Ethical approvalThis study was approved in the Research Department of Guilan University of Medical Sciences with the ethics code of IR.GUMS.REC.1398.437 and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Written Informed consent was obtained from all individual adult participants included in this study. The consent form for illiterate people was read by their first degree relatives and in the absence of the first family, the form was read by one of their trusted
Declaration of Competing InterestThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
AcknowledgementsThe authors gratefully acknowledge the all participants in the Caspian Digestive Disease Research Center and Gastrointestinal and Liver Disease Research Center for their assistance in the data collection process, and vice-chancellor of research of Guilan University of medical science for their financial support.
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