Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

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.
    

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 deficiency anemia refractory to iron supplementation among children infected
      with Helicobacter pylori, most without evident ulcers, clearly indicate that such cases have
      been cured of their anemia after receiving a course of Helicobacter pylori eradication
      therapy. Several studies based on national surveys, including one on the U.S. National Health
      and Nutrition Examination Survey data and conducted by the authors of this proposal, have
      found an association between Helicobacter pylori infection and the levels of iron stores.
      However, these studies fail to demonstrate that anemia follows Helicobacter pylori infection.
      Moreover, most previous research has been conducted outside of the contiguous U.S. and has
      not included young children, one of the high-risk populations for iron deficiency and iron
      deficiency anemia. Data on this age-group is most needed to develop sound public health
      interventions.

      We propose to conduct such a study among children living in El Paso, Texas, a city located on
      the U.S.-Mexico border. A series of studies have been conducted in that city by the authors
      of this proposal, including a National Institutes of Health sponsored study aiming to
      describe the natural history of Helicobacter pylori infection in children from birth to age
      seven years (84 months). We 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. Currently, the clinical
      management of the most extreme form of iron deficiency, that is iron deficiency anemia,
      relies only on supplemental iron therapy. For ethical reasons, our study will identify
      children with anemia from the study, and will assign them to one of the arms receiving iron
      supplementation. Our study will determine whether a combination of iron supplementation and
      sequential Helicobacter pylori eradication therapy yields higher increases of iron stores
      than each of these treatments alone. To summarize, our main hypothesis is that Helicobacter
      pylori infection is associated with iron deficiency such that Helicobacter pylori eradication
      would result in an increase in the levels of:

        1. serum ferritin,

        2. transferrin saturation, and

        3. hemoglobin.

      To test these hypotheses we will randomly assign 125 Helicobacter pylori-infected children (3
      to 10 years of age) into each of the following four groups: Helicobacter pylori eradication
      treatment, iron supplementation, Helicobacter pylori eradication plus iron supplementation,
      or placebo. We plan to recruit infected children through a household survey in El Paso,
      screen their Helicobacter pylori infection status by a stool test, and invite their parents
      to undergo a confirmatory breath test. Infected children randomly allocated to those four
      arms of the study will be followed closely during the 6 weeks they are taking the study
      medication to record any adverse event, followed by a visit at 45 days after treatment to
      tell whether or not those receiving the medication had their infection eradicated, between 6
      and 12 months for hematological evaluation to compare with the baseline levels of iron
      stores.
    

Intervention name(s): Quadruple sequential Helicobacter pylori eradication + iron sulfate; Quadruple sequential Helicobacter pylori eradication therapy; Ferrous sulfate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation; A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation; 6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy; Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Iron deficiency; Helicobacter infection; Epidemiology