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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03231332 |
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Date of registration:
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21/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of H.Pylori Eradication on Microbiome
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Scientific title:
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Long Term Effects of H.Pylori Eradication on Microbiome and Adverse Events |
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Date of first enrolment:
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July 29, 2017 |
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Target sample size:
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900 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03231332 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Latvia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals with established H.pylori infection
- Individuals in whom H.pylori eradication therapy is indicated according to the
international or national recommendations
- Individuals who agree to undergo H.pylori eradication therapy
Exclusion Criteria:
- Severely sick patients
- Individuals in whom H.pylori eradication therapy is contra-indicated due to any
reasons
- Individuals unable or unwilling to provide a sample for microbiome testing
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Human Microbiome
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Intervention(s)
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Other: Microbiome Diversity detection
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Primary Outcome(s)
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Effects of various H.pylori eradication regimens upon the gut microbiome
[Time Frame: 6-36 months between the initial and the follow-up sample]
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Secondary Outcome(s)
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Effects of various H.pylori eradication regimens upon adverse events in short term
[Time Frame: 21-28 days following the expected starting data of the treatmennt]
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Effects of various H.pylori eradication regimens upon long-lasting adverse events
[Time Frame: 6 months - 10 years following eradication]
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Effectiveness of various H.pylori eradication regimens
[Time Frame: 1-12 months following eradication therapy]
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Effects of various H.pylori eradication regimens upon the pharyngeal microbiome
[Time Frame: 6-36 months between the initial and the follow-up sample]
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Secondary ID(s)
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1.1.1.1/16/A/272
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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