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The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the stomach and that this effect of the infection can be identified among persons with iron deficiency as well as among persons with normal iron stores. The aim of this study is to determine whether Helicobacter pylori eradication in children is followed by an increase in markers of iron stores after six to twelve months of treatment.
For the last 12 years, scientific evidence has mounted linking Helicobacter pylori infection with iron deficiency and iron deficiency anemia. Reports from around the world on several cases of iron deficiency anemia refractory to iron supplementation among children infected with Helicobacter pylori, most without evident ulcers, clearly indicate that such cases have been cured of their anemia after receiving a course of Helicobacter pylori eradication therapy. Several studies based on national surveys, including one on the U.S. National Health and Nutrition Examination Survey data and conducted by the authors of this proposal, have found an association between Helicobacter pylori infection and the levels of iron stores. However, these studies fail to demonstrate that anemia follows Helicobacter pylori infection. Moreover, most previous research has been conducted outside of the contiguous U.S. and has not included young children, one of the high-risk populations for iron deficiency and iron deficiency anemia. Data on this age-group is most needed to develop sound public health interventions.
We propose to conduct such a study among children living in El Paso, Texas, a city located on the U.S.-Mexico border. A series of studies have been conducted in that city by the authors of this proposal, including a National Institutes of Health sponsored study aiming to describe the natural history of Helicobacter pylori infection in children from birth to age seven years (84 months). We hypothesize that the Helicobacter pylori bacterium decreases iron from the stomach and that this effect of the infection can be identified among persons with iron deficiency as well as among persons with normal iron stores. Currently, the clinical management of the most extreme form of iron deficiency, that is iron deficiency anemia, relies only on supplemental iron therapy. For ethical reasons, our study will identify children with anemia from the study, and will assign them to one of the arms receiving iron supplementation. Our study will determine whether a combination of iron supplementation and sequential Helicobacter pylori eradication therapy yields higher increases of iron stores than each of these treatments alone. To summarize, our main hypothesis is that Helicobacter pylori infection is associated with iron deficiency such that Helicobacter pylori eradication would result in an increase in the levels of:
1. serum ferritin,
2. transferrin saturation, and
To test these hypotheses we will randomly assign 125 Helicobacter pylori-infected children (3 to 10 years of age) into each of the following four groups: Helicobacter pylori eradication treatment, iron supplementation, Helicobacter pylori eradication plus iron supplementation, or placebo. We plan to recruit infected children through a household survey in El Paso, screen their Helicobacter pylori infection status by a stool test, and invite their parents to undergo a confirmatory breath test. Infected children randomly allocated to those four arms of the study will be followed closely during the 6 weeks they are taking the study medication to record any adverse event, followed by a visit at 45 days after treatment to tell whether or not those receiving the medication had their infection eradicated, between 6 and 12 months for hematological evaluation to compare with the baseline levels of iron stores.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Quadruple sequential Helicobacter pylori eradication + iron sulfate, Quadruple sequential Helicobacter pylori eradication therapy, Ferrous sulfate, Placebo
Texas Tech University School of Medicine
The University of Texas Health Science Center, Houston
Published on BioPortfolio: 2014-07-23T21:35:33-0400
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A spiral bacterium active as a human gastric pathogen. It is a gram-negative, urease-positive, curved or slightly spiral organism initially isolated in 1982 from patients with lesions of gastritis or peptic ulcers in Western Australia. Helicobacter pylori was originally classified in the genus CAMPYLOBACTER, but RNA sequencing, cellular fatty acid profiles, growth patterns, and other taxonomic characteristics indicate that the micro-organism should be included in the genus HELICOBACTER. It has been officially transferred to Helicobacter gen. nov. (see Int J Syst Bacteriol 1989 Oct;39(4):297-405).
Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.
A species of gram-negative, spiral-shaped bacteria found in the gastric mucosa that is associated with chronic antral gastritis. This bacterium was first discovered in samples removed at endoscopy from patients investigated for HELICOBACTER PYLORI colonization.
Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).
Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.
Peptic Ulcer Disease
Peptic Ulcer Disease - stomach ulcer, duodenal ulcers used to refer to all types of peptic ulcers. A peptic ulcer is an erosion in a segment of the Gastrointestinal (GI) muscularis mucosae, typically in the stomach (gastric ulcer) or the first few cent...
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