Status:
COMPLETED
Helicobacter in The Gambia (Part 1)
Lead Sponsor:
Medical Research Council Unit, The Gambia
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Helicobacter Pylori
Eligibility:
All Genders
6+ years
Brief Summary
H. pylori infection causes the stomach to become inflamed. The problem usually begins in childhood and leads to stomach problems in adult life. Study participants will be residents of The Gambia, West...
Detailed Description
The overall goal in this pilot project is to implement and evaluate a new method for isolating Helicobacter pylori (H. pylori) strains from young children, and to compare these isolates with those obt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00466700
Start Date
July 1 2007
End Date
March 1 2009
Last Update
May 8 2015
Active Locations (1)
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1
Medical Research Council's Laboratories
Banjul, The Gambia