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

NCT03722433 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-10-31

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Vigiis 101-LAB and sequential therapy

Vigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile.

DRUG

Placebo and sequential therapy

Placebo without Vigiis 101-LAB component

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2019-07-31
Completion
2020-07-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722433 on ClinicalTrials.gov