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OpenTrials
Completed

NCT Number: NCT02725138

Efficacy of Probiotics in the Gut Microbiota and H Pylori Density

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.

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Key information

Conditions

Helicobacter

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks

Placebo

Other

Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks

Primary outcomes

  1. Reduction of bacterial load of H. pylori

    Time frame: after 4 weeks of treatment

Secondary outcomes

  1. changes in gut microbiota

    Time frame: after 4 weeks of treatment

  2. adverse effects

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Statistical Center, NTUHCTC

Other

Collaborators

  • Taiwan Sugar Cooperation Company

Registry information

Official study title

The Efficacy of Lactobacillus Acidophilus and Lactobacillus Rhamnosus in the Modification of Gut Microbiota and Reduction of Helicobacter Pylori Bacterial Load- a Double Blind, Placebo Controlled, Randomized Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Mar 31, 2016
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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