Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion
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|ClinicalTrials.gov Identifier: NCT02051348|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HELICOBACTER INFECTION||Biological: Pylopass Biological: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Single-blinded, Placebo Controlled, Crossover Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Placebo Comparator: Placebo
Placebo - 2 doses per day for 4 weeks
Active Comparator: Pylopass
Probiotic - 2 doses per day for 4 weeks
- Efficacy of Pylopass to reduce H pylori load by urease breath test (UBT) [ Time Frame: Up to 8 weeks ]
- Symptoms, using the Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Up to 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051348
|Atlantia Food Clinical Trials, University College Cork|
|Principal Investigator:||Martin JM Buckley, MRCPI, FRCPI||Mercy University Hospital|