Status:
UNKNOWN
Supplementation With L. Reuteri in H. Pylori Infected Adults
Lead Sponsor:
Lama Medical Care s.r.o.
Collaborating Sponsors:
BioGaia AB
Conditions:
Dyspepsia
H. Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can eradicate H. pylori in humans in the absence of antibiotics.
Detailed Description
Fifty-six (56) subjects, aged 18-70 years will be recruited from patients with dyspeptic symptoms referred to the clinic for consultation about H. pylori infection and who have not previously been tre...
Eligibility Criteria
Inclusion
- Subjects aged 18-70 years
- Infection with H. pylori defined by endoscopic examination with biopsy H. pylori staining
- Non-ulcer dyspepsia
- Absence of other pathology as shown by basic clinical laboratory tests (blood and urine) as well as abdominal ultrasound
- 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 :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01449500
Start Date
October 1 2011
End Date
April 1 2012
Last Update
October 10 2011
Active Locations (1)
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1
Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5
Bratislava, Slovakia, 81107