PMID- 32897519
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231112
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 9
IP  - 4
DP  - 2020 Dec
TI  - Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with 
      Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled 
      Trial.
PG  - 867-878
LID - 10.1007/s40121-020-00333-2 [doi]
AB  - INTRODUCTION: Antibiotic treatment can alter the gut microbiome and cause 
      short-term gastrointestinal adverse effects (AEs). This study assessed the 
      efficacy of lyophilized capsules containing 2 x 10(9) spores of Bacillus clausii 
      (Enterogermina((R)); Sanofi Synthelabo) in reducing AEs associated with 
      Helicobacter pylori eradication therapy in Italy. METHODS: In this randomized, 
      double-blind, single-center, phase IIIB study, 130 adult outpatients with H. 
      pylori infection were assigned to receive one Enterogermina((R)) capsule or placebo 
      three times daily for 2 weeks (1:1). During week 1, all patients received 
      clarithromycin 500 mg, amoxicillin 1 g, and rabeprazole 20 mg twice daily. The 
      primary efficacy outcome was the presence of diarrhea in week 1. RESULTS: A total 
      of 130 patients were randomized. The incidence of diarrhea in week 1 was 29% in 
      the B. clausii group and 48% in the placebo group [relative risk (RR) 0.61; 95% 
      confidence interval (CI) 0.39-0.97; p = 0.03]. The incidence of diarrhea remained 
      lower with B. clausii than with placebo in week 2 (RR 0.38; 95% CI 0.14-1.02; 
      p = 0.0422). In week 1, the number of days without diarrhea was significantly 
      higher in the B. clausii group than in the placebo group (6.25 vs. 5.86; 
      p = 0.0304). In both groups, the number of days without diarrhea increased 
      significantly (p < 0.0001) from week 1 to week 2. A total of three AEs occurred 
      in two patients in the placebo group, but none were serious. CONCLUSIONS: 
      Compared with placebo, Enterogermina((R)) reduced the incidence of, and the number 
      of days with, diarrhea in patients receiving H. pylori eradication therapy. 
      Enterogermina(R) was well tolerated.
FAU - Plomer, Manuel
AU  - Plomer M
AD  - Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Hochst, 
      Frankfurt am Main, Germany.
FAU - Iii Perez, Marcos
AU  - Iii Perez M
AD  - Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Hochst, 
      Frankfurt am Main, Germany.
FAU - Greifenberg, Dorothea Maren
AU  - Greifenberg DM
AD  - Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Hochst, 
      Frankfurt am Main, Germany. Dorothea.Greifenberg@sanofi.com.
LA  - eng
PT  - Journal Article
DEP - 20200908
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
EIN - Infect Dis Ther. 2020 Sep 28;:. PMID: 32986227
PMC - PMC7680487
OTO - NOTNLM
OT  - Bacillus clausii
OT  - Clinical trial
OT  - Diarrhea
OT  - Enterogermina
OT  - Eradication therapy
OT  - Helicobacter pylori
OT  - Probiotics
EDAT- 2020/09/09 06:00
MHDA- 2020/09/09 06:01
PMCR- 2020/09/08
CRDT- 2020/09/08 12:16
PHST- 2020/07/16 00:00 [received]
PHST- 2020/09/09 06:00 [pubmed]
PHST- 2020/09/09 06:01 [medline]
PHST- 2020/09/08 12:16 [entrez]
PHST- 2020/09/08 00:00 [pmc-release]
AID - 10.1007/s40121-020-00333-2 [pii]
AID - 333 [pii]
AID - 10.1007/s40121-020-00333-2 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2020 Dec;9(4):867-878. doi: 10.1007/s40121-020-00333-2. Epub 
      2020 Sep 8.