- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466700
Helicobacter in The Gambia (Part 1)
Genotypes of Helicobacter Pylori in West African Children and Adults: Part 1: The Development and Evaluation of Minimally Invasive Techniques for Obtaining H. Pylori Isolates From Adults and Children in The Gambia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Banjul, Gambia
- Medical Research Council's Laboratories
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult Subjects: All consenting subjects referred for diagnostic upper endoscopy to the Medical Research Council (MRC) unit in Fajara will be eligible for inclusion, provided none of the exclusion criteria apply. In The Gambia, subjects aged 18 years and above are considered as adult. Subjects will be sampled only once.
Child Subjects: All subjects under 2 years of age referred for diagnostic upper endoscopy to the MRC unit in Fajara will be eligible for inclusion, provided their parents give informed consent and that none of the exclusion criteria apply. The minimum cut-off age for this study will be 6 months.
Exclusion Criteria:
Adult Subjects: Any contraindication to endoscopy and biopsy, such as as liver dysfunction, history of bleeding, history of other serious organ disease (for example, kidney, heart, lung), bleeding time prolonged to over 10 minutes, or unexpected findings such as esophageal or gastric stricture that limits endoscopic examination will exclude subjects from the study, as will the use of antibiotics during the previous 2 weeks. Specific tests such as bleeding times will be performed at the discretion of the supervising clinician, who is undertaking the diagnostic endoscopy for the subject's clinical benefit. In addition, if the endoscopist feels that prolonging the procedure by 2 or 3 minutes in order to take the research biopsies would not be advisable for any reason, the subject will be excluded from the study.
Child Subjects: Any contraindication to endoscopy and biopsy, such as as liver dysfunction, history of bleeding, history of other serious organ disease (for example, kidney, heart, lung), bleeding time prolonged to over 10 minutes, or unexpected findings such as esophageal stricture that limits endoscopic examination will exclude subjects from the study, as will the use of antibiotics during the previous 2 weeks. In addition, if the endoscopist feels that prolonging the procedure by 2 or 3 minutes in order to take the research biopsies would not be advisable for any reason, the subject will be excluded from the study. Specific tests such as bleeding times will be performed at the discretion of the supervising clinician, who is undertaking the diagnostic endoscopy for the subject's clinical benefit.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of relatedness between bacterial isolates
Time Frame: 4 years
|
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. There are no outcome measures for human subjects. All laboratory investigations will be conducted upon bacterial isolates There are no outcome measures for human subjects. All laboratory investigations will be conducted upon bacterial isolates |
4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Adegbola, PhD, FRCPath, Medical Research Council Unit, The Gambia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 06-0053
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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