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Trial record 43 of 150 for:    tetracycline

Helicobacter Pylori and Body Iron in Adults (HEISA)

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ClinicalTrials.gov Identifier: NCT03146325
Recruitment Status : Withdrawn (Study was not funded and PI has left the institution)
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE Drug: MATCHING PLACEBO Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Helicobacter Pylori and Body Iron in Adults
Study Start Date : November 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: PYLERA AND OMEPRAZOLE
14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID)
Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
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
Other Names:
  • PYLERA
  • OTC OMEPRAZOLE

Placebo Comparator: PLACEBO
MATCHING PLACEBOS
Drug: MATCHING PLACEBO
TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY




Primary Outcome Measures :
  1. Serum Ferritin [ Time Frame: 6 months after completing therapy ]
    Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein


Secondary Outcome Measures :
  1. Body Iron [ Time Frame: 6 months after completing therapy ]
    Changes from baseline estimated by the ratio of log base 10 of serum transferrin receptor over serum ferritin

  2. Other markers of iron stores, and erythropoiesis [ Time Frame: 6 months after completing therapy ]
    Changes from baseline transferrin saturation, zinc protoporphyrin to estimate free-erythrocyte protoporphyrin, and hemoglobin



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146325


Locations
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United States, Texas
Sparks Community Center
El Paso, Texas, United States, 79928
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Baylor College of Medicine

Publications:
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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03146325     History of Changes
Other Study ID Numbers: HEISA
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by The University of Texas Health Science Center, Houston:
H. pylori infection
Additional relevant MeSH terms:
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Tetracycline
Infection
Metronidazole
Omeprazole
Bismuth
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Protein Synthesis Inhibitors