The Efficacy and Safety of Furazolidone-bismuth Quadruple Therapy for Eradication with or Without Probiotic Supplementation

Aim: In this clinical trial we use furazolidone-bismuth quadruple therapy with or without probiotics for eradication.

Background: Increasing rates of eradication failure in infection mainly due to antibiotic resistance has led to search for alternative regimens such as using novel antibiotics and/or using probiotic supplementation as conjunctive to the standard eradication regimens.

Methods: This double blind clinical trial was performed in gastrointestinal clinic of Loghman Hakim University Hospital, Tehran, Iran. Patients with a positive pathology test for were enrolled to the study and received a 14 day course of furazolidone 100 mg q.i.d, bismuth 240 mg b.i.d, amoxicillin 1000 mg b.i.d, pantoprazole 40 mg b.i.d plus either probiotic (Familact) b.i.d or placebo b.i.d. Adverse effects and adherence to therapy were evaluated at the end of the treatment course. Eradication was established by fecal antigen test.

Results: A total of 200 patients entered the study and were randomly assigned to two groups of placebo and probiotic. There was no significant difference regarding age or gender between placebo and probiotic groups. Adherence to therapy was higher than 90% in total and not significantly different between placebo and probiotic groups. Total eradication rate was 80.5% (n=161). Eradication rate was 84% in probiotic group vs 77% in placebo group (P=0.2). Total rate of adverse effects was 30% in probiotic group vs 62% in placebo group. The most common adverse effects were abdominal pain (15% in probiotic group vs 28% in placebo group, P=0.03) followed by diarrhea (5% in probiotic group vs 12% in placebo group, P=0.1).

Conclusion: According to our results, adding probiotic to furazolidone-bismuth quadruple therapy did no increase the eradication rate significantly. However, adverse effects particularly abdominal pain was lower in the probiotic group when compared with placebo.