Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion

NCT02051348 | Completed Phase 2

• 1 other identifier: AFCRO-046
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

HELICOBACTER INFECTION

Keywords

Helicobacter pylori; Mild Indigestion

Outcome Measures

Primary Outcomes (1)

• Efficacy of Pylopass to reduce H pylori load by urease breath test (UBT)

  Up to 8 weeks

Secondary Outcomes (1)

• Symptoms, using the Gastrointestinal Symptom Rating Scale (GSRS)

  Up to 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo - 2 doses per day for 4 weeks

Biological: Pylopass; Biological: Placebo

Pylopass

ACTIVE COMPARATOR

Probiotic - 2 doses per day for 4 weeks

Biological: Pylopass; Biological: Placebo

Interventions

Pylopass BIOLOGICAL

Pylopass

Placebo; Pylopass

Placebo BIOLOGICAL

Placebo

Placebo; Pylopass

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be considered eligible for enrolment into the study, subjects must;
• Be able to give written informed consent,
• Be between 18 and 75 years of age,
• Be in generally good health as determined by the investigator OR have mild gastrointestinal discomfort, such as mild indigestion,
• Have a positive urease breath test (\> 1.5)

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the below criteria;
• Are less than 18 and greater than 75 years of age,
• Females are pregnant, lactating or wish to become pregnant during the study.
• Are hypersensitive to any of the components of the test product,
• Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
• Have an active gastrointestinal disorder or previous gastrointestinal surgery,
• 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,
• Have taking antibiotics in the past 3 months,
• Prior eradication therapy with antibiotics for H. pylori infection,
• Have not made any major dietary changes in the past 3 months,
• Are taking non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks of baseline visit or for the duration of the trial,
• History of illicit drug use,
• 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,
• Subjects may not be receiving treatment involving experimental drugs,
• If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study,

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead

Study Sites (1)

Atlantia Food Clinical Trials, University College Cork

Cork, Ireland

Location

Related Publications (1)

• Buckley M, Lacey S, Doolan A, Goodbody E, Seamans K. The effect of Lactobacillus reuteri supplementation in Helicobacter pylori infection: a placebo-controlled, single-blind study. BMC Nutr. 2018 Dec 7;4:48. doi: 10.1186/s40795-018-0257-4. eCollection 2018.

  PMID: 32153909 DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Martin JM Buckley, MRCPI, FRCPI

  Mercy University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: January 31, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

IE (1)