Effect of Bacillus clausii capsules in H-Pylori
Effect of Bacillus clausii capsules* in reducing adverse effects associated with Helicobacter eradication therapy
Manuel Plomer, Marcos III Perez, Dorothea Maren Greifenberg
Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial. Infect Dis Ther. 2020 Sep 8.
Introduction
Treatment of Helicobacter pylori (H. pylori) infection can alter the gut microbiota and lead to gastrointestinal adverse effects (AEs)1
- H. pylori infection is treated with a combination of antibiotics and proton pump inhibitors (PPIs) for 1 week
- Antibiotics used for the treatment of H. pylori infection, such as amoxicillin, can have prolonged negative impacts on the gut microbiome which may take several weeks to recover if it all2
- Microbial diversity is decreased, effecting the abundance of beneficial commensals and detrimental microorganisms3
PPIs and the gut microbiome
- Use of PPIs to treat H. pylori infection alters the composition of the gut microbiome,4 which may:
- Increase the risk of enteric infections and bacterial translocation to the blood5
- Promote the onset of gastrointestinal disorders6
- There are at least two known mechanisms of this effect7
- Direct targeting of bacterial proton pumps
- Inhibition of gastric acid secretion (altering the gut microenvironment)
Abbreviation
PPI=proton pump inhibitor
Study Objective
- A previous study using a vial formulation of B. clausii in patients undergoing 7-day triple therapy for H. pylori infection also showed a decrease in the incidence of diarrhea compared to patients given a placebo8
- Probiotics may reduce gastrointestinal adverse effects associated with H. pylori infection9
- This study aimed to assess the efficacy of a spore-based probiotic containing spores of four antibiotic-resistant Bacillus clausii (B.clausii) strains (Enterogermina®) in capsule formulation in reducing and preventing the AEs associated with H. pylori eradication therapy
Study Design
A randomized, double-blind, single-center, phase IIIB study conducted between 2003–2004
Primary outcome:
- Presence of diarrhea at week 1
Secondary outcomes:
- Number of days without diarrhea
- Daily frequency of diarrhea
- Presence/absence of other gastrointestinal symptoms during weeks 1–2
Results
Patient disposition and demographics
| Demographic Data | B. Clausii (n=65) |
Placebo (n=65) |
| Male, n (%) 3 | 28 (43.08) | 26 (40.00) |
| Female, n (%) | 37 (56.92) | 39 (60.00) |
| Age, years, mean (SD) | 44.23 (13.48) | 42.38 (13.02) |
Incidence of symptoms
- In both week 1 and week 2, there was significantly less diarrhea in the B. clausii treatment group
Prevention of adverse effects by Bacillus clausii capsules
Days without symptoms
- Patients receiving B. clausii had significantly more days without diarrhea than patients receiving placebo (6.25 vs 5.86; p=0.0304)
Safety and tolerability
- Three AEs were reported in the study in two placebo recipients:
- Gastrointestinal mycosis and gastroenteritis (both in the same patient); mild aphthous stomatitis (one patient)
- There were no serious AEs or AEs related to study treatment
- Patients' global assessment of tolerability was similar in
both treatment groups
Abbreviation
AE=adverse effect
Conclusions
Enterogermina®
significantly reduced the incidence of diarrhea was well tolerated in patients receiving eradication therapy H. pylori eradication therapy
This study suggests that B. clausii probiotics can ameliorate the negative effect of PPIs on the gut microbiota.
Abbreviations
AE=adverse effect; PPI=proton pump inhib
Summary
| Treatment of H. pylori infection with antibiotics and/or PPIs can cause gastrointestinal AEs | → | Probiotics have been shown to reduce AEs | → | 130 patients receiving H. pylori eradication therapy were randomised (1:1) to receive Enterogermina® or placebo |
Frequency of diarrhea (primary endpoint)
- Week 1: 29% in the B. clausii group compared with 48% in the placebo group (p=0.03)
- Week 2: incidence remained significantly lower
Number of days without symptoms
- Number of days without diarrhea was 6.25 with B. clausii vs 5.86 with placebo (p=0.0304)
Enterogermina®was well tolerated and reduced incidence of gastrointestinal AEs
Abbreviations
AE=adverse effect; PPI=proton pump inhibitor
Prevention of adverse effects by Bacillus clausii capsules
References
- Bhalodi AA, van Engelen TSR, Virk HS, Wiersinga WJ. Impact of antimicrobial therapy on the gut microbiome. J Antimicrob Chemother. 2019 Jan 1;74(Suppl 1):i6-i15
- Lin H, Wang Q, Yuan M, Liu L, Chen Z, Zhao Y, Das R, Duan Y, Xu X, Xue Y, Luo Y, Mao D. The prolonged disruption of a single-course amoxicillin on mice gut microbiota and resistome, and recovery by inulin, Bifidobacterium longum and fecal microbiota transplantation. Environ Pollut. 2020 Oct;265(Pt A):114651.
- Zimmermann P, Curtis N. The effect of antibiotics on the composition of the intestinal microbiota - a systematic review. J Infect. 2019 Dec;79(6):471-489.
- Macke L, Schulz C, Koletzko L, Malfertheiner P. Systematic review: the effects of proton pump inhibitors on the microbiome of the digestive tract-evidence from next-generation sequencing studies. Aliment Pharmacol Ther. 2020 Mar;51(5):505-526.
- Hojo M, Asahara T, Nagahara A, Takeda T, Matsumoto K, Ueyama H, Matsumoto K, Asaoka D, Takahashi T, Nomoto K, Yamashiro Y, Watanabe S. Gut Microbiota Composition Before and After Use of Proton Pump Inhibitors. Dig Dis Sci. 2018 Nov;63(11):2940-2949.
- Bruno G, Zaccari P, Rocco G, et al. Proton pump inhibitors and dysbiosis: Current knowledge and aspects to be clarified. World J Gastroenterol. 2019;25(22):2706-2719. doi:10.3748/wjg.v25.i22.2706
- Dong T, Pisegna J. Passing the "Acid Test": Do Proton Pump Inhibitors Affect the Composition of the Microbiome? Dig Dis Sci. 2018 Nov;63(11):2817-2819.
- Nista EC, Candelli M, Cremonini F, Cazzato IA, Zocco MA, Franceschi F, Cammarota G, Gasbarrini G, Gasbarrini A. Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial. Aliment Pharmacol Ther. 2004 Nov 15;20(10):1181-8.
- Homan M, Orel R. Are probiotics useful in Helicobacter pylori eradication? World J Gastroenterol. 2015 Oct 7;21(37):10644-53.
* Enterogermina 2B capsules/SuspensionGULF PIL July 2019 Bacillus Clausii in H-Pylori - 2021
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Dosage: children & breast-feeding infants: 1 - 2 vials a day; adults: 2-3 bottles a day or 2-3 capsules a day or 1 sachet a day. Side Effects: There have been reports of allergic reactions (hypersensitivity), including skin rash, urticaria and angioedema. In case of side effects, please contact your physician or pharmacist. Pregnancy and lactation: Enterogermina may be used during pregnancy and lactation. Talk to your doctor or pharmacist before taking this medicine.
