Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Vigiis 101-LAB and sequential therapy; Drug: Placebo and sequential therapy

• Registration Number: NCT03722433
• Lead Sponsor: National Taiwan University Hospital

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

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-08-29
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-28
• Study First Posted: 2018-10-29
• Last Update Posted: 2018-10-31
• Primary Completion: 2019-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic plus 14-day sequential therapy	Vigiis 101-LAB and 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
placebo plus 14-day sequential therapy	Placebo and 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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse effects in the first line therapy in the two treatment groups	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 Outcome Measures

Name	Time	Method
Eradication rates in the first line treatment in the two treatment groups	6 weeks	Urea breath testing will be done at least 6 weeks after completion of eradication therapy.

Trial Locations

Locations (1)

Jyh-Ming Liou; 🇨🇳 Taipei, Taiwan, Taiwan