Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children

Completed · Phase 3 · Has a placebo group

Conditions studied: Iron Deficiency

In brief

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.

Key facts

Study ID

NCT00364104

Run by

The University of Texas Health Science Center, Houston

People needed

125

Starts

2007-03-01

Expected to finish

2008-12-01

Last updated by the study team

2009-06-30

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children 3-10 years of age
• Helicobacter pylori infected, asymptomatic
• Healthy otherwise
• Parents provided consent/assenting children 7-10 years of age

You may not qualify if…

• 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

Where it is running

• Texas Tech University School of Medicine — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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