The Efficacy of Probiotic Supplementation in the Reduction of Adverse Effects and Dysbiosis of Helicobacter Pylori Eradication Therapy - A Double Blind, Multi-center Randomized, Placebo Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Incidence of adverse effects in the first line therapy in the two treatment groups
Study Overview
Brief Summary
The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Detailed Description
Backgroud: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and the recurrence rate of peptic ulcer disease. However, the adverse effects, such as diarrhea and abdominal pain occurred in about 20-30% of patient during eradication therapies for H. pylori. Dysbiosis of the gut microbiota might contribute to the adverse effects.
Aims: Therefore, the investigators aimed to assess the efficacy of probiotic supplementation during the eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Methods:
This will be a double-blind, placebo controlled, multi-center randomized trial. 200 patients with H. pylori infection naïve to eradication therapy will be enrolled.
Before First Line Treatment: Any two positive of CLO test, histology, serology and culture or a positive UBT will be considered as H. pylori infected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.
Exclusion Criteria
- •children and teenagers aged less than 20 years
- •history of gastrectomy
- •gastric malignancy, including adenocarcinoma and lymphoma
- •previous allergic reaction to antibiotics (amoxicillin, metronidazole, clarithromycin, probiotics) and PPI (esomeprazole)
- •contraindication to treatment drugs
- •pregnant or lactating women
- •severe concurrent disease
- •concomitant use of clopidogrel
- •unwilling to accept random assignment of subjects
Arms & Interventions
probiotic plus 14-day sequential therapy
D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Intervention: Vigiis 101-LAB and sequential therapy (Drug)
placebo plus 14-day sequential therapy
D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Intervention: Placebo and sequential therapy (Drug)
Outcomes
Primary Outcomes
Incidence of adverse effects in the first line therapy in the two treatment groups
Time Frame: 8 weeks
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events and compliance at the end of treatment. Patients with low compliance as defined by taking less than 80% of the pills and those lost to follow up will be excluded from the per-protocol analysis.
Secondary Outcomes
- Eradication rates in the first line treatment in the two treatment groups(6 weeks)