Helicobacter in The Gambia (Part 1)

NCT00466700 | Completed

• 1 other identifier: 06-0053
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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 Africa, and will be studied at the Medical Research Council of Great Britain facility in Fajara, The Gambia. Up to 75 adults 18 years and older and 20 malnourished children 6 months to 2 years of age, who are undergoing endoscopy as part of their medical care, will be studied. (Endoscopy is when a thin, lighted device is used to look inside the body.) During this study procedure, tiny pieces of tissue, called biopsies, will be taken from the stomach and checked for H. pylori infection. Participants found to be infected will be given antibiotic treatment. Participation in the study will last approximately 72 hours.

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

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.
• 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.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Medical Research Council's Laboratories

Banjul, The Gambia

Location

Study Officials

• Richard Adegbola, PhD, FRCPath

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

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 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: March 1, 2009
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

TH (1)