Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
This trial is active, not recruiting.
|Conditions||helicobacter pylori infection, dyspepsia|
|Treatments||lactobacillus reuteri, placebo|
|Sponsor||Centro Regional para el Estudio de las Enfermedades Digestivas|
|Start date||December 2009|
|End date||September 2011|
|Trial size||100 participants|
|Trial identifier||NCT01028690, lactobacilos vs helicobacter|
Helicobacter pylori colonizes approximately to 50% of the world-wide population.
There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.
The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
time frame: 28 days
To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scoring within and between L. reuteri and placebo-supplemented subjects
time frame: 101 days
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Subjects aged 18 - 65 years - Infection with H. pylori defined as ∆ > 20 ppm in the UBT 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 Criteria: - Duodenal or gastric ulcer - MALT lymphoma - Penicillin allergy - 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
|Official title||Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri|
|Principal investigator||Francisco J Bosques, MD PhD|
|Description||The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.|
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