Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children

NCT00364104 | Completed Phase 3 DMC

• 1 other identifier: HSC-SPH-06-0374
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Iron Deficiency

Keywords

Iron deficiency; Helicobacter infection; Epidemiology

Outcome Measures

Primary Outcomes (3)

• Percent change of serum ferritin

  between 6 and 12 months

• Percent change of transferrin saturation

  between 6 and 12 months

• Percent change of hemoglobin

  between 6 and 12 months

Secondary Outcomes (1)

• Proportion of children who cleared their H. pylori infection

  45+ days after completing treatment

Study Arms (4)

A

EXPERIMENTAL

A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation

Drug: Quadruple sequential Helicobacter pylori eradication + iron sulfate

B

EXPERIMENTAL

The 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation

Drug: Quadruple sequential Helicobacter pylori eradication therapy

C

EXPERIMENTAL

6-weeks of iron supplementation only plus 10-days of matching placebo of Hp infection eradication therapy

Drug: Ferrous sulfate

D

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quadruple sequential Helicobacter pylori eradication + iron sulfate DRUG

A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation

A

Quadruple sequential Helicobacter pylori eradication therapy DRUG

A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation

B

Ferrous sulfate DRUG

6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy

C

Placebo DRUG

Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).

D

Eligibility Criteria

• Age: 36 Months - 120 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Tech University: collaborator
• University of Texas: collaborator
• Baylor College of Medicine: collaborator
• University of North Texas Health Science Center: collaborator

Study Sites (1)

Texas Tech University School of Medicine

El Paso, Texas, 79905, United States

Location

Related Publications (2)

• Cardenas VM, Prieto-Jimenez CA, Mulla ZD, Rivera JO, Dominguez DC, Graham DY, Ortiz M. Helicobacter pylori eradication and change in markers of iron stores among non-iron-deficient children in El Paso, Texas: an etiologic intervention study. J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):326-32. doi: 10.1097/MPG.0b013e3182054123.

  PMID: 21336159 DERIVED

• Prieto-Jimenez CA, Cardenas VM, Fischbach LA, Mulla ZD, Rivera JO, Dominguez DC, Graham DY, Ortiz M. Double-blind randomized trial of quadruple sequential Helicobacter pylori eradication therapy in asymptomatic infected children in El Paso, Texas. J Pediatr Gastroenterol Nutr. 2011 Mar;52(3):319-25. doi: 10.1097/MPG.0b013e318206870e.

  PMID: 21336156 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Helicobacter Infections

Interventions

Iron-Dextran Complex; ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Victor M Cardenas, MD, MPH, PhD

  University of Texas-Houston School of Public Health El Paso Regional Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

US (1)