Efficacy of Probiotics in the Gut Microbiota and H Pylori Density

Phase 2

Completed

• Conditions: Helicobacter
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT02725138
• Lead Sponsor: Statistical Center, NTUHCTC

Brief Summary

We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.

Detailed Description

Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-27
• Study First Submitted QC: 2016-03-27
• Study First Posted: 2016-03-31
• Primary Completion: 2017-01
• Study Completion: 2020-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-27
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial

Exclusion Criteria

• history of gastrectomy and colectomy
• severe underlying illness, such as malignancy, ESRD, liver failure, etc
• allergy to probiotics
• symptomatic patients who need PPI, antibiotics, or other probiotics
• pregnancy and lactating women
• unable to cooperate with the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	subjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks
Placebo	Placebo	subjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks

Primary Outcome Measures

Name	Time	Method
Reduction of bacterial load of H. pylori	after 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
changes in gut microbiota	after 4 weeks of treatment
adverse effects	4 weeks

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan