Helicobacter Pylori InfectionPhase 4HEISANCT03146325
Helicobacter Pylori and Body Iron in Adults
A Phase 4 study testing BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE in people with Helicobacter Pylori Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE, MATCHING PLACEBO
- Keywords
- H. pylori infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLEDrug
Also called PYLERA, OTC 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
MATCHING PLACEBODrug
TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY
| Study group | Role | What they receive |
|---|---|---|
| PYLERA AND OMEPRAZOLE | Experimental | 14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID) Receives: Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE |
| PLACEBO | Placebo comparator | MATCHING PLACEBOS Receives: Drug: MATCHING PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Ferritin
Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein
Measured: 6 months after completing therapy
Secondary outcomes (2)
Body Iron
Changes from baseline estimated by the ratio of log base 10 of serum transferrin receptor over serum ferritin
Measured: 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
Measured: 6 months after completing therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startNov 2012
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Study was not funded and PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146325
- Sponsor's protocol ID
- HEISA
- Acronym
- HEISA
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21336159
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori and Body Iron in Adults
- ClinicalTrials.gov ID
- NCT03146325
- Acronym / sponsor ID
- HEISA / HEISA
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H. pylori infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded and PI has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Nov 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PYLERA AND OMEPRAZOLE | Experimental | Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE14-DAY COURSE OF 3-1 PYLERA (3 CAPSULES QID) PLUS OMEPRAZOLE (BID) |
| PLACEBO | Placebo comparator | Drug: MATCHING PLACEBOMATCHING PLACEBOS |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLEAlso: PYLERA, OTC OMEPRAZOLEA 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 | Drug | PYLERA AND OMEPRAZOLE |
| MATCHING PLACEBOTO BE PREPARED BY LICENSED COMPOUNDING PHARMACY | Drug | PLACEBO |
Primary outcome
Serum Ferritin
Time frame: 6 months after completing therapy
Changes from baseline at 6 months after completing therapy, controlled by C-reactive protein
2 secondary outcomes
Body Iron
Time frame: 6 months after completing therapy
Other markers of iron stores, and erythropoiesis
Time frame: 6 months after completing therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 21336159Cardenas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE in people with Helicobacter Pylori Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Ferritin (time frame: 6 months after completing therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03146325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.