Status:
COMPLETED
Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Texas Tech University
University of Texas
Conditions:
Iron Deficiency
Eligibility:
All Genders
36-120 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 def...
Eligibility Criteria
Inclusion
- Children 3-10 years of age
- Helicobacter pylori infected, asymptomatic
- Healthy otherwise
- Parents provided consent/assenting children 7-10 years of age
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00364104
Start Date
March 1 2007
End Date
December 1 2008
Last Update
June 30 2009
Active Locations (1)
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1
Texas Tech University School of Medicine
El Paso, Texas, United States, 79905