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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
Sponsor:
Information provided by (Responsible Party):
Atlantia Food Clinical Trials

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo - 2 doses per day for 4 weeks
Biological: Pylopass
Pylopass

Biological: Placebo
Placebo

Active Comparator: Pylopass
Probiotic - 2 doses per day for 4 weeks
Biological: Pylopass
Pylopass

Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Efficacy of Pylopass to reduce H pylori load by urease breath test (UBT) [ Time Frame: Up to 8 weeks ]

Secondary Outcome Measures :
  1. Symptoms, using the Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Up to 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be considered eligible for enrolment into the study, subjects must;

  1. Be able to give written informed consent,
  2. Be between 18 and 75 years of age,
  3. Be in generally good health as determined by the investigator OR have mild gastrointestinal discomfort, such as mild indigestion,
  4. Have a positive urease breath test (> 1.5)

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

  1. Are less than 18 and greater than 75 years of age,
  2. Females are pregnant, lactating or wish to become pregnant during the study.
  3. Are hypersensitive to any of the components of the test product,
  4. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
  5. Have an active gastrointestinal disorder or previous gastrointestinal surgery,
  6. Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include proton pump inhibitors or gastroprotective medicines,
  7. Have taking antibiotics in the past 3 months,
  8. Prior eradication therapy with antibiotics for H. pylori infection,
  9. Have not made any major dietary changes in the past 3 months,
  10. Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
  11. History of illicit drug use,
  12. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
  13. Subjects may not be receiving treatment involving experimental drugs,
  14. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study,
  15. Have a malignant disease or any concomitant end-stage organ disease,

Information from the National Library of Medicine

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


Locations
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Ireland
Atlantia Food Clinical Trials, University College Cork
Cork, Ireland
Sponsors and Collaborators
Atlantia Food Clinical Trials
Investigators
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Principal Investigator: Martin JM Buckley, MRCPI, FRCPI Mercy University Hospital

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Responsible Party: Atlantia Food Clinical Trials
ClinicalTrials.gov Identifier: NCT02051348     History of Changes
Other Study ID Numbers: AFCRO-046
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Atlantia Food Clinical Trials:
Helicobacter pylori
Mild Indigestion

Additional relevant MeSH terms:
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Helicobacter Infections
Dyspepsia
Gram-Negative Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms