Supplementation With L. Reuteri in H. Pylori Infected Adults
NCT ID: NCT01449500
Last Updated: 2011-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2011-10-31
2012-04-30
Brief Summary
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Detailed Description
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After randomisation on Day 0 of the study, the subjects will also be asked to complete a gastrointestinal symptom rating score (GSRS) to determine baseline symptomology.
Intervention will begin on Day 1 and last for 28 days after which therapy will be stopped. The subjects will be asked to complete the GSRS questionnaire on Day 14 and Day 28. At Day 14, the patients GSRS scores are monitored and the patients interviewed. In those patients where there is a marked deterioration of their condition or symptoms, these will be considered treatment failures and eradication therapy will then be started on Day 15.
The day after therapy is stopped (Day 29), patients symptoms will be assessed. All patients will undergo gastroscopy to determine the presence of H. pylori or not. If H. pylori infection is confirmed (by endoscopy and biopsy staining), these subjects will be given triple therapy to eradicate the infection and followed up on Day 90 of the study.
On Day 29, those patients that no longer complain of symptoms and are shown to be free of H. pylori infection by endoscopy (treatment success group), will continue with no further therapy until Day 90.
On Day 90 all subjects will be given a UBT to determine the presence of H. pylori infection and symptoms will be again assessed using GSRS. Asymptomatic patients with negative breath test will be considered recovered. In those patients where persistent H. pylori infection is confirmed by breath test, second line therapy will be implemented as indicated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Chewable tablet, one tablet per day for 28 days
L. reuteri
L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day.
Intervention: Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475
L. reuteri
Chewable tablet, one tablet/day for 28 days
Interventions
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L. reuteri
Chewable tablet, one tablet/day for 28 days
Placebo
Chewable tablet, one tablet per day for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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BioGaia AB
INDUSTRY
Lama Medical Care s.r.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Ladislav Kuzela, MD
Role: PRINCIPAL_INVESTIGATOR
Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5, 811 07, Bratislava, Slovakia
Locations
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Gastroenterology Hepatology Centrum THALION, Poliklinika Mytna - 2.poscodie Mytna ul. 5
Bratislava, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSUB0028
Identifier Type: -
Identifier Source: org_study_id