NCT02051348

A Single-blinded, Placebo Controlled, Crossover Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion

Completed Phase 2/Phase 3 Last updated 14 January 2015

What this trial tests

Phase 2/Phase 3 trial testing Pylopass in HELICOBACTER INFECTION in 24 participants. Completed in 1 December 2014.

Timeline

1 January 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Atlantia Food Clinical Trials
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	1 January 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across Ireland

Drugs / interventions tested

• Pylopass — full drug profile →
• Placebo

Conditions studied

• HELICOBACTER INFECTION — all drugs for HELICOBACTER INFECTION →

Sponsor

Atlantia Food Clinical Trials — full company profile →

Who can join

Adults 18 to 75, any sex, with HELICOBACTER INFECTION. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy of Pylopass to reduce H pylori load by urease breath test (UBT)
  Time frame: Up to 8 weeks

Sponsor's own description

Helicobator pylori (H. pylori) is a bacteria which survives in the lining of the stomach. An estimated 50% of the world's population is infected with H. pylori. Developing economies, such as in Southeast Asia, the Indian subcontinent and Latin America, have prevalence rates of as high as 90%.

H. pylori infection often goes undiagnosed, as many sufferers do not experience any adverse symptoms. Infection with H. pylori is described as "not a disease in itself but a condition that affects the relative risk of developing various clinical disorders of the upper gastrointestinal tract.' Clinically relevant symptoms could include peptic ulcer, melena or secondary conditions such as iron deficiency anemia or vitamin B12 deficiency.

There is evidence that probiotics can be beneficial for those with gastrointestinal diseases. Pylopass contains the probiotic strain Lactobacillus reuteri, which was selected for its anti-H. pylori characteristics and in clinical trials has shown to result in a reduction in urease breath test values in subjects with H. pylori.

The objective of this study is to evaluate the ability of Pylopass to reduce H. pylori load in subjects who are H. pylori positive.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Probiotics as the live microscopic fighters against Helicobacter pylori gastric infections.
   Keikha M, Karbalaei M. · · 2021 · cited 48× · PMID 34670526 · DOI 10.1186/s12876-021-01977-1
2. The effect of <i>Lactobacillus reuteri</i> supplementation in <i>Helicobacter pylori</i> infection: a placebo-controlled, single-blind study.
   Buckley M, Lacey S, Doolan A, Goodbody E, et al · · 2018 · cited 21× · PMID 32153909 · DOI 10.1186/s40795-018-0257-4