Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Baylor College of Medicine; Texas Tech University; University of North Texas Health Science Center; University of Texas
• Treatments: Iron

Criteria

Inclusion Criteria:

• Children 3-10 years of age

• Helicobacter pylori infected, asymptomatic

• Healthy otherwise

• Parents provided consent/assenting children 7-10 years of age

Exclusion Criteria:

• Parental consent or child assent not obtained

• History of antibiotic-related allergic episodes

• Children with a history of allergy, asthma, hay fever or urticaria

• Phenylketonurics

• Abnormal renal and hepatic functions as evaluated through albumin, bilirubin, AST (or SGOT), ALT (or SGPT), alkaline phosphatase and GGT-P

• History of peptic ulcer

• History of recent (< 1 month) severe disease

• History of recent (< 1 month) use of antibiotics, antacids, H2 receptor antagonists, proton pump inhibitors and remedies containing bismuth

• Parents uncertain about staying in El Paso for the next year