Helicobacter Pylori and Body Iron in Adults

Study Overview
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Brief Summary
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This study is an etiologic trial to test the hypothesis that predicts that Helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. The study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective FDA approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now OTC. We have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on PP analysis. We need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on ITT basis and safely conclude that H pylori leads to a deficit of body iron.

Detailed Description
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This etiologic double-blind randomized trial in non-anemic mostly asymptomatic/mildly dyspeptic Hp-infected adults will assess whether Hp eradication results in improvements in the levels of iron stores. Iron stores will be assessed by (i) SF as primary outcome, and the following secondary outcomes: (ii) serum transferrin receptor (sTfR), (iii) the ratio of sTfR to SF or R/F, which will be used to estimate body iron, (iv) transferrin saturation (TS), (v) zinc protoporhyrin (ZPP) and (vi) hemoglobin (Hb) at baseline and at 6 months of follow-up. This study is a double-blind randomized clinical trial (RCT) of Hp eradication allocating 400 Hp-infected asymptomatic/mildly dyspeptic adults 18-65 years of age of El Paso, Texas, to receive either (i) a 14-day quadruple Hp eradication therapy described above or (ii) placebo. We expect that at least 240 will complete the study medications and follow-up.

Official Title
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Helicobacter Pylori and Body Iron in Adults

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
* Drug: MATCHING PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-65, men and women, residents of the geographic target area in El Paso, Texas, who consent to participate and complete at least 10 days of the study medication. Exclusion Criteria: Unsure if they stay in the area, have a history of allergic reactions to any antibiotic, lack adequate specimen for culture, phenylketonurics, women who are pregnant or unwilling to use 2 modern contraceptive methods during the 2-weeks they take the medications, with a history of heavy menses, anemic, history of peptic ulcer disease or had received Helicobacter eradication therapy or have abnormal lab results for kidney and liver functions tests. Will hold the enrollment for 4 weeks to those taking PPI, bismuth salts and antibiotics, and for 3 months since last blood transfusion or receiving intravenous iron preparations.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PYLERA AND OMEPRAZOLE<br>14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID) | Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE<br>* A 14-day quadruple Hp eradication therapy consisting of: omeprazole (20 mg twice daily) plus 3 capsules q.i.d., each containing 420 mg of bismuth subcitrate potassium, 375 mg of metronidazole and 375 mg of tetracycline hydrochloride, for 14 days<br>* Other names: OTC OMEPRAZOLE;|
| Placebo Comparator: PLACEBO<br>MATCHING PLACEBOS | Drug: MATCHING PLACEBO<br>* TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Ferritin | Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein | 6 months after completing therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Iron | Changes from baseline estimated by the ratio of log base 10 of serum transferrin receptor over serum ferritin | 6 months after completing therapy | 
| Other markers of iron stores, and erythropoiesis | Changes from baseline transferrin saturation, zinc protoporphyrin to estimate free-erythrocyte protoporphyrin, and hemoglobin | 6 months after completing therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H. pylori infection