Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Conditions
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Helicobacter Pylori Infection, Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri<br>L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans | Dietary Supplement: Lactobacillus reuteri<br>* Lactobacillus reuteri is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475; will be delivered at a dose of 1x108 CFU of each strain. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Will be taken daily throughout the entire study, from the day of inclusion to the final analysis at the end of follow-up after eradication therapy. Will be delivered either in a chewable tablet form<br>* Other names: Progastria;|
| Placebo Comparator: placebo<br>Placebo will be delivered in a chewable tablet form (1.5g per dose) | Dietary Supplement: Placebo<br>* placebo<br>* Other names: bioGaia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 101 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Eradication therapy, Lactobacillus reuteri, Dyspeptic symptoms