Helicobacter in The Gambia (Part 2)

NCT00467155 | Withdrawn

• 1 other identifier: 06-0004
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine Helicobacter pylori bacteria in the stomach fluids of children who are hospitalized and receiving nutritional care via nasogastric feeding (tube from the nose to the stomach) to treat malnutrition. The H. pylori strains from Gambian children may differ genetically from the strains found in the stomachs of adults from the same community. The fluid samples will be examined for H. pylori bacterial infections that may make children sick and unable to absorb food. Ninety hospitalized Gambian children, less than 2 years of age, requiring a nasogastric feeding tube will have stomach fluid samples taken via the gastric tube. Thirty mothers of children who are positive for H. pylori bacteria will provide a sample of stomach fluid. This study may help develop treatments to heal the stomach and improve child growth. This study will be conducted at the Medical Research Council of Great Britain Research Laboratories and Clinical Facility in Fajara.

Conditions

Helicobacter Pylori

Keywords

Helicobacter pylori, children, infants, Gambia

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.

Eligibility Criteria

• Age: 3 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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. Subjects will comprise; i) children who have a nasogastric tube inserted for nutritional rehabilitation on the ward at Fajara; ii) mothers of children who are found to be H. pylori positive.

You may qualify if:

• Subjects will be sampled only once.
• Subjects cannot be included if they do not agree to provide Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: June 1, 2007
• Last Updated: September 24, 2015

Record last verified: 2015-04