The Effect of <i>Bacillus polyfermenticus </i>Therapy on Reducing Side Effects during <i>Helicobacter pylori</i> Eradication Therapy: Randomized, Double-blinded, Controlled Trial

Original Article

The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2009;9(2):66-74.
Published online December 30, 2009.

The Effect of Bacillus polyfermenticus Therapy on Reducing Side Effects during Helicobacter pylori Eradication Therapy: Randomized, Double-blinded, Controlled Trial

Helicobacter pylori균 박멸 요법 시 발생하는 부작용 감소에 대한 Bacillus polyfermenticus의 효과: 무작위, 이중맹검, 치료약 대조 임상시험

박선자ㆍ박무인ㆍ김재현ㆍ송근암*ㆍ김광하*ㆍ설상영^†ㆍ김지현^†ㆍ박성재^†박유수^‡ㆍ손철훈^‡ㆍ박은진^‡

고신대학교 복음병원 소화기내과, 부산대학교병원 소화기내과*, 인제대학교 부산백병원 소화기내과^†, (주) 바이넥스^‡

Abstract

Background/Aims
Helicobacter pylori (H. pylori) eradication fails in many patients, mainly because of the occurrence of resistance to antibiotics and side-effects. In this study, we compared the effects of Bacillus polyfermenticus with Bacillus subtilis and Streptococcus faecium on H. pylori eradication. Methods: 205 patients who confirmed H. pylori positive by screening were randomly allocated to be treated biscan^Ⱂ (Bacillus polyfermenticus) or medilac DS^Ⱂ (Bacillus subtilis, Streptococcus faecium) in a double-blind, prospective manner. All patients were treated by rabeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 gm twice in a day for 1 week, and combination with biscan^Ⱂ or medilac DS^Ⱂ for 2 weeks. Patients completed validated questionnaires during the week of treatment and following to determine the type and severity of side-effects and tolerability. Results: The incidence of diarrhea was lower in biscan^Ⱂ group than medilac DS^Ⱂ group, but not statistically significant. There was no significant difference in other symptoms of the two groups. An overall assessment of treatment tolerability showed no significant difference between the two groups. In this study, drug-related serious adverse events did not occur. Conclusions: Bacillus polyfermenticus is not inferior to Bacillus subtilis and Streptococcus faecium and is a safe and useful probiotic agent for the gastrointestinal side-effects during H. pylori eradication therapy.. (The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2009;9:66-74)

Key Words: Probiotics, H. pylori eradication, Bacillus polyfermenticus