Status:
COMPLETED
Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors
Lead Sponsor:
St Marina University Hospital, Varna, Bulgaria
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.
Detailed Description
Helicobacter pylori colonises an estimated 50% of the world´s population. Despite clear clinical guidelines on the treatment of this infection there is a drive to find alternative ways to control this...
Eligibility Criteria
Inclusion
- Infection with H. pylori defined using the 13C-urea breath test
- Non-ulcer dyspepsia
- No earlier eradication therapy for H. pylori infection
- Written informed consent
- Stated availability throughout the entire study period
- Mental ability to understand and willingness to fulfil all the details of the protocol.
Exclusion
- Duodenal or gastric ulcer
- MALT lymphoma
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
- Absence of GI symptoms
- Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
- Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
- Pregnancy
- Participation in other clinical trials
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01456728
Start Date
January 1 2011
End Date
September 1 2013
Last Update
September 10 2013
Active Locations (1)
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1
Department of Gastroenterology and Hepatology, St Marina University Hospital
Varna, Bulgaria, Bulgaria, 9010