Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 7, 2009 | ||||
| Last Updated Date | June 21, 2011 | ||||
| Start Date ICMJE | December 2009 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01028690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri | ||||
| Official Title ICMJE | Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri | ||||
| Brief Summary | 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. |
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| Detailed 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01028690 | ||||
| Other Study ID Numbers ICMJE | lactobacilos vs helicobacter | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Francisco Javier Bosques Padilla, Centro Regional Para el Estudio de las Enfermedades Digestivas | ||||
| Study Sponsor ICMJE | Centro Regional para el Estudio de las Enfermedades Digestivas | ||||
| Collaborators ICMJE | BioGaia AB | ||||
| Investigators ICMJE |
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| Information Provided By | Centro Regional para el Estudio de las Enfermedades Digestivas | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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