Efficacy and Safety of Lacidofil STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia

  • STATUS
    Not Recruiting
  • days left to enroll
    4
  • participants needed
    100
  • sponsor
    Lallemand Health Solutions
Updated on 10 October 2022
antibiotic therapy
antibiotics
dyspepsia

Summary

Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its efficiency (lower capability to eradicate the infection) due to increasing antibiotic resistance in the population. But the addition of probiotics to the treatment has been observed to increase efficiency, and decreasing the antibiotics' side effects. We set to evaluate whether Lacidofil STRONG improves efficacy when added to the standard therapy to eradicate H. pylori.

Description

This study aims at evaluating the efficacy of Lacidofil STRONG as an adjuvant therapy to a standard 14-day H. pylori eradication treatment among H. pylori-positive participants with non-ulcer dyspepsia.

This is a randomized, placebo-controlled trial, with two parallel arms. Participants will be randomized to receive probiotic or placebo as adjuvant to the standard anti-H. pylori treatment. Each participant will be enrolled in the study for 12 weeks, during which they will receive the anti-H. pylori treatment and co-administration of investigational product (IP; for two weeks), followed by IP supplementation alone (for four weeks), and they will be followed-up 4 weeks after last IP administration.

Details
Condition H. Pylori Infection, Helicobacter Pylori Infection
Treatment Placebo, Lacidofil
Clinical Study IdentifierNCT04473079
SponsorLallemand Health Solutions
Last Modified on10 October 2022

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