Efficacy of Probiotics in the Gut Microbiota and H Pylori Density

Statistical Center, NTUHCTC

Status and phase: Completed; Phase 3; Phase 2

Conditions: Helicobacter

Treatments: Dietary Supplement: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02725138

201511071RIPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

subjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

subjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks

Treatment:

Other: Placebo