Clinical trial NCT03722433: Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse effects in the first line therapy in the two treatment groups
timeFrame: 8 weeks
Secondary outcomes:
measure: Eradication rates in the first line treatment in the two treatment groups
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Jyh-Ming Liou
Study officials:
References: