MedTrace Logo

Eradication of Helicobacter Pylori With a Lactobacillus Reuteri Strain Plus Proton Pump Inhibitor

NCT03404440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-01-19

No results posted yet for this study

Summary

Meta-analyses involving \>4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy in populations with antibiotic resistance have reported a mean increase in eradication rate of 12.2%. It is unclear how to translate that result into clinical practice.

To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections.

This was a double-blind placebo-controlled randomized 2 site study of L. reuteri (2 x 108 CFU L. reuteri DSM 17938 plus 2 x 108 CFU L. reuteri ATCC PTA 6475) 7 times per day or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size was based on obtaining \>50% cures to be clinically useful as monotherapy.

Conditions

  • Helicobacter Pylori Infection

Interventions

OTHER

L.Reuteri

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • University of Bari

    lead OTHER

Principal Investigators

  • ruggiero francavilla, Md PhD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2017-06-30
Completion
2017-11-01

Countries

  • Italy

Study Locations

More Related Trials

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 NCT03404440 on ClinicalTrials.gov