Helicobacter Pylori Clinical Trial
Official title:
Genotypes of Helicobacter Pylori in West African Children and Adults: Part 2: The Application of a Minimally Invasive Technique for H. Pylori Isolation in a Population Study
NCT number | NCT00467155 |
Other study ID # | 06-0004 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | April 26, 2007 |
Last updated | September 23, 2015 |
Start date | June 2007 |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 23 Months |
Eligibility |
Inclusion Criteria: Children: All children under the age of 2 years who are inpatients on the MRC ward and who have a nasogastric tube in situ for the purposes of re-nutrition or other medical management, will be eligible for inclusion. Children must be positive for H. pylori. No lower age limit is specified for the purposes of this study, but an audit of clinical cases shows that all children admitted to the MRC ward who would be eligible for inclusion are aged over 3 months. Children aged under 3 months will not be enrolled. Adults: Mothers of H. pylori positive children will be eligible for inclusion. In The Gambia subjects aged 18 years and above are considered as adult. Subjects will be sampled only once. Subjects cannot be included if they do not agree to provide Informed Consent Exclusion Criteria: 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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical Research Council Unit, The Gambia | National Institute of Allergy and Infectious Diseases (NIAID) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
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