Trials Sponsors Conditions Drugs Pricing

Conditions

Helicobacter Pylori

Keywords

Helicobacter pylori, Gambia, endoscopy, Africa

Outcome Measures

Primary Outcomes (1)

The degree of relatedness between bacterial isolates
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

Eligibility Criteria

Age6 Months+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will consist of rural subsistence farmers and semi-urban dwellers attending the clinic at the MRC research laboratories in Fajara, The Gambia. The study will be comprised of subjects who are undergoing endoscopy for diagnostic purposes within the endoscopy unit at Fajara.

You may not qualify if:

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.

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHcollaborator
Medical Research Council Unit, The Gambia
Otherlead

Study Sites (1)

Medical Research Council's Laboratories

Banjul, The Gambia

Study Officials

Richard Adegbola, PhD, FRCPath
Medical Research Council Unit, The Gambia
PRINCIPAL INVESTIGATOR

Enrollment

75 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

Helicobacter in The Gambia (Part 1)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations