Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer. The standard first-line treatment for H. pylori eradication is bismuth-containing quadruple therapy. While effective, this aggressive, multi-antibiotic regimen frequently induces significant gastrointestinal adverse effects and severe disruption of the normal gut microbiota (dysbiosis). These side effects often lead to poor patient compliance, which in turn contributes to treatment failure and the increasing global challenge of antibiotic resistance.
Emerging clinical evidence strongly supports the use of probiotics as an adjuvant therapy to alleviate antibiotic-associated side effects and significantly aid in restoring intestinal balance. Spore-forming Bacillus species, specifically Bacillus clausii, Bacillus subtilis, and Bacillus coagulans, are particularly advantageous due to their natural resistance to acidic gastric conditions and concurrent antibiotic administration, allowing them to remain viable and active during the intensive eradication therapy.
This clinical trial is designed as a randomised, double-blind, placebo-controlled study to evaluate the clinical efficacy, adverse effects, and treatment adherence of a standard four-drug bismuth-containing regimen for the treatment of H. pylori infection when combined with single-strain and multi-strain Bacillus probiotics.
The trial is conducted in the Gastroenterology Department of Tam Anh Hospital. 336 participants diagnosed with H. pylori infection and prescribed the standard 14-day bismuth-containing quadruple therapy are randomly divided and allocated to receive either a single-strain probiotic (LiveSpo Clausy), a multi-strain probiotic (LiveSpo DIA 30), or an identical placebo.
Over 8 weeks of follow-up, participants will be assessed at predefined time points for antibiotic-associated adverse events, gastrointestinal symptoms, stool form, treatment adherence, and Helicobacter pylori eradication status. Stool samples will be collected before and after treatment to evaluate faecal IgA levels, the presence of Bacillus strains, and changes in gut microbiota using real-time PCR, ELISA, and 16S rRNA sequencing.
Patients aged 18 to 65 years;
Diagnosed with H. pylori infection by the 13C-urea breath test or the rapid urease test;
Indicated for H. pylori eradication treatment with the four-drug bismuth regimen (BQT);
Agree to participate in the study and have been informed and signed the consent form
Active bleeding gastric or duodenal ulcer.
Use of antibiotics, acid-suppressing drugs (PPIs, H2RAs), non-steroidal anti-inflammatory drugs (NSAIDs), laxatives, antidiarrheals, or probiotics (excluding yogurt) within at least 4 weeks before participating in the study, except for laxatives used as part of the study's endoscopic preparation procedure.
Chronic inflammatory bowel disease (IBD), acute intestinal infection, gastrointestinal cancer (stomach cancer, colon cancer), acute or chronic pancreatitis, immunosuppression (including prolonged corticosteroid use), or psychiatric disorders.
Alcohol abuse, history of delirium tremens, or alcoholic liver disease.
Parallel
RO water
Other interventionRO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LiveSpo Clausy / Dia30 but contain 5 mL of high-quality RO water from Aquafina.
LiveSpo CLAUSY
Combination productLiveSpo® CLAUSY has a registration number 4071/2021/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
LiveSpo DIA30
Combination productLiveSpo® DIA30 has a registration number 6547/2019/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.
Antibiotic-Associated Adverse Event Rate and Severity
The proportion and severity of antibiotic-associated adverse events during H. pylori eradication therapy are assessed using the Antibiotic-Associated Adverse Events Questionnaire (AAE-Q) during the first 2 weeks of treatment. The assessed symptoms include: fatigue, loss of appetite, dizziness, headache, diarrhoea, and nausea/vomiting. The key evaluation time point will be week 2, with changes assessed from baseline/week 0 to week 2. The week 1, 4, and 8 visits will serve as interim supportive time points.
Change in Gastrointestinal Symptom Score
Gastrointestinal symptoms are assessed using the Gastrointestinal Symptom Rating Scale (GSRS), at baseline, after completion of H. pylori eradication therapy, and during the post-treatment follow-up period. The key evaluation time point will be week 2, with changes assessed from baseline/week 0 to week 2. The week 8 visits will serve as interim supportive time points.
Change in Stool Consistency
Stool consistency will be assessed using the Bristol Stool Scale (BSS) at baseline, after completion of H. pylori eradication therapy, and during the post-treatment follow-up period. The key evaluation time point will be week 2, with changes assessed from baseline/week 0 to week 2. The week 8 visits will serve as interim supportive time points.
Treatment Adherence
Treatment adherence during 2 week of of H. pylori eradication therapy is measured with the Medication Adherence Report Scale-5 (MARS-5), consisting of five questions that assess medication-taking behaviors such as forgetting to take medication, altering the dose, discontinuing medication, skipping doses, and taking less medication than prescribed. The key evaluation time point will be week 2 and week 1 point will serve as an interim supportive time point.
Pill Count Adherence Rate
Adherence to H. pylori eradication therapy will be assessed by counting the number of medications used compared with the number prescribed. At each follow-up time point, participants who have taken ≥90% of the prescribed medications will be considered adherent to treatment. The key evaluation time point will be week 2.
H. pylori Eradication Rate
H. pylori eradication will be assessed using the 13C-urea breath test at baseline, after completion of H. pylori eradication therapy, and during the post-treatment follow-up period. The key evaluation time point will be week 8, with changes assessed from baseline/week 0 to week 8.
Change in Fecal Secretory IgA Concentration
Changes in fecal sIgA concentration are measured and compared within each group over time and among the study groups at 3 time points. The main exploratory comparison will be the change from Week 0 to Week 2, while Week 8 will serve as a follow-up time point to evaluate sustained or delayed changes
Gut microbiota composition
Changes in gut microbiota composition are evaluated using 16S rRNA gene sequencing of stool samples. The outcomes include diversity indices and the relative taxonomic composition at major levels such as phylum, family, and genus. The key evaluation time point will be week 2, with changes assessed from baseline/week 0 to week 2.
Detection of probiotic Bacillus spores in stool
Presence of B. subtilis, B. clausii, and B. coagulans spores in stool as determined by real-time PCR, used as an exploratory indicator of exposure to the assigned probiotic products and adherence to the intervention across 3 main follow-up timepoints. The main exploratory time point will be Week 2, while Week 8 will be used as a follow-up time point.
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Anabio R&D
Lead sponsor
Tam Anh Research Institute
Collaborator
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