- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467155
Helicobacter in The Gambia (Part 2)
Genotypes of Helicobacter Pylori in West African Children and Adults: Part 2: The Application of a Minimally Invasive Technique for H. Pylori Isolation in a Population Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Children: All children under the age of 2 years who are inpatients on the MRC ward and who have a nasogastric tube in situ for the purposes of re-nutrition or other medical management, will be eligible for inclusion. Children must be positive for H. pylori. No lower age limit is specified for the purposes of this study, but an audit of clinical cases shows that all children admitted to the MRC ward who would be eligible for inclusion are aged over 3 months. Children aged under 3 months will not be enrolled.
Adults: Mothers of H. pylori positive children will be eligible for inclusion. In The Gambia subjects aged 18 years and above are considered as adult.
Subjects will be sampled only once.
Subjects cannot be included if they do not agree to provide Informed Consent
Exclusion Criteria:
The use of antibiotics during the 2 weeks prior to recruitment will exclude subjects from the study. Subjects who have participated in any other clinical trial within the last 30 days will be excluded
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
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The degree of relatedness between bacterial isolates
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This will be assessed by visual comparison between RAPD results, by comparison of genotypes for alleles of interest, and definitively by sequencing of housekeeping genes to construct phylogenetic trees of relatedness, using the STAR program (a computer program for putting DNA sequences together for analysis) and MLST database.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 06-0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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