Helicobacter Pylori Infection Clinical Trial
Official title:
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
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.
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.
After First Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8
weeks after 14-day sequential therapy
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year
after14-day sequential therapy
Interventions: First line therapy: eligible patients will be randomized into one of the two
groups.
Group (A): 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
Group (B): 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
Follow-up
1. The stool samples will be collected before, and 2 and 8 weeks and 1 year after
eradication therapy to analyze the changes in the antibiotic resistance and microbiota
of gut flora
2. The body weight, waist and hip circumference and serum lipid profile, sugar, and HBA1C
levels will be collected before , and 2 and 8 weeks and 1 year after eradication therapy
3. Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to
determine the minimum inhibitory concentrations of antibiotics. Mutations in 23S rRNA
will also be determined by PCR followed by direct sequencing
Outcome Measurement:
Primary End Point: Incidence of adverse effects in the first line therapy in the two
treatment groups
Secondary End Point:
1. Eradication rates in the first line treatment in the two treatment groups
2. Changes of gut microbiota in the two treatment groups
3. Antibiotic resistance of gut flora after first line treatments in the two treatment
groups
4. Re-infection rate one year after eradication therapy
;
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