Efficacy of Probiotics in the Gut Microbiota and H Pylori Density

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Helicobacter

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>subjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks | Dietary Supplement: Probiotic<br>* Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks<br>|
| Placebo Comparator: Placebo<br>subjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks | Other: Placebo<br>* Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bacterial load of H. pylori |  | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in gut microbiota |  | after 4 weeks of treatment | 
| adverse effects |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, probiotic, bacterial density