Back to resultsHelicobacter Pylori and Body Iron in Adults (HEISA)
Primary Purpose
Helicobacter Pylori Infection
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
MATCHING PLACEBO
Sponsored by
About this trial
This is an interventional prevention trial for Helicobacter Pylori Infection focused on measuring H. pylori infection
Eligibility Criteria
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.
Sites / Locations
- Sparks Community Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PYLERA AND OMEPRAZOLE
PLACEBO
Arm Description
14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID)
MATCHING PLACEBOS
Outcomes
Primary Outcome Measures
Serum Ferritin
Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein
Secondary Outcome Measures
Body Iron
Changes from baseline estimated by the ratio of log base 10 of serum transferrin receptor over serum ferritin
Other markers of iron stores, and erythropoiesis
Changes from baseline transferrin saturation, zinc protoporphyrin to estimate free-erythrocyte protoporphyrin, and hemoglobin
Full Information
NCT ID
NCT03146325
First Posted
May 5, 2017
Last Updated
May 5, 2017
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03146325
Brief Title
Helicobacter Pylori and Body Iron in Adults
Acronym
HEISA
Official Title
Helicobacter Pylori and Body Iron in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not funded and PI has left the institution
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
H. pylori infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PYLERA AND OMEPRAZOLE
Arm Type
Experimental
Arm Description
14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID)
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
MATCHING PLACEBOS
Intervention Type
Drug
Intervention Name(s)
BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
Other Intervention Name(s)
PYLERA, OTC OMEPRAZOLE
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MATCHING PLACEBO
Intervention Description
TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY
Primary Outcome Measure Information:
Title
Serum Ferritin
Description
Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein
Time Frame
6 months after completing therapy
Secondary Outcome Measure Information:
Title
Body Iron
Description
Changes from baseline estimated by the ratio of log base 10 of serum transferrin receptor over serum ferritin
Time Frame
6 months after completing therapy
Title
Other markers of iron stores, and erythropoiesis
Description
Changes from baseline transferrin saturation, zinc protoporphyrin to estimate free-erythrocyte protoporphyrin, and hemoglobin
Time Frame
6 months after completing therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Sparks Community Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79928
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21336159
Citation
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.
Results Reference
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Helicobacter Pylori and Body Iron in Adults
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