Is Helicobacter Pylori Infection a Cause or Treatment Failure of Iron Deficiency Anemia in Children in Bangladesh?
Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
Participant gender:
Summary
Helicobacter pylori is recognized as a major gastrointestinal pathogen in developing
countries. This microorganism infects up to 60% of children less than five years in those
countries and is strongly associated with chronic gastritis and peptic ulcer disease in
children and adults. The progression of gastritis to atrophy often leads to decreased gastric
acid output, which is a well-known risk factor for anemia. Gastric acid is essential for
increasing the bioavailability and absorption of non-heme dietary iron, the most important
source of iron in developing countries. Numerous reports suggest that iron malabsorption
secondary to low gastric acid output is a problem in developing world countries. It has been
further observed that iron deficiency anemia is resistant to iron therapy particularly in
these countries. In a recently completed study we observed an association of anaemia with H.
pylori infection. We hypothesize that the poor bioavailability of iron in these countries
could be related to H. pylori -induced low gastric acid output and we propose to investigate
the role of H. pylori infection as a cause of anemia and treatment failure of iron
supplementation in Bangladesh. A prospective, randomized, double-blind, placebo-controlled
field trial is proposed among four groups ( 65 each) of H. Pylori infected children of 2-5
years of age with iron deficiency anemia. The children will be assigned to one of the four
therapies: antibiotics alone (for H. Pylori eradication), antibiotic plus iron therapy, iron
therapy alone, or placebo. Hemoglobin concentration, serum ferritin concentration, and
transferrin receptor will be measured before and at 1 and 3 month after the intervention. We
also propose a complementary study in an additional 20 children with H. Pylori infection and
iron deficiency anemia to assess iron absorption with application of double stable isotopes.
The change in hematological parameters will also be compared among the groups before and
after the therapy. The results of this study are expected to have implications in the
prevention and treatment of iron deficiency anemia in developing countries.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh