Immune Thrombocytopenic PurpuraNCT07150286
Helicobacter Pylori Eradication Therapy for Immune Thrombocytopenia (ITP) Patients in Iraq
A study testing Levofloxacin-Based H. pylori Eradication Therapy in people with Immune Thrombocytopenic Purpura and HELICOBACTER PYLORI INFECTIONS, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
This study is being conducted to evaluate the effect of treating Helicobacter pylori infection on platelet counts in patients with immune thrombocytopenia (ITP). ITP is a condition in which the body's immune system attacks its own platelets, leading to an increased risk of bleeding and bruising. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura, HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Levofloxacin-Based H. pylori Eradication Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2024to 1 Apr 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with a confirmed diagnosis of ITP Platelet count <100,000/µL. H. pylori-positive or H. pylori-negative based on stool antigen test
Who cannot join
- • Patients with other causes of thrombocytopenia (e.g., leukemia, aplastic anemia).
- Severe comorbidities (e.g., uncontrolled diabetes, severe cardiac disease).
- Recent use (within 4 weeks) of antibiotics, proton pump inhibitors, or bismuth compounds.
- Concurrent use of medications that interfere with H. pylori therapy or platelet levels.
- Pregnant or lactating women.
- Known allergy or intolerance to eradication therapy agents (clarithromycin, amoxicillin, metronidazole).
- High risk of poor compliance (e.g., psychiatric illness).
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Al-Mustansiriyah University - college of pharmacy - clinical pharmacy department
Baghdad, Baghdad Governorate, 10001
About this study
Official title: Assessment of Hematological Effect of H.Pylori and H.Pylori Eradication Therapy Among a Sample of Iraqi ITP Patients
This study is being conducted to evaluate the effect of treating Helicobacter pylori infection on platelet counts in patients with immune thrombocytopenia (ITP). ITP is a condition in which the body's immune system attacks its own platelets, leading to an increased risk of bleeding and bruising. Some studies have suggested that removing H. pylori infection may help improve platelet counts in certain patients with ITP.
In this study, 100 patients with ITP will be enrolled at hematology centers in Baghdad. Patients will be tested for H. pylori infection using stool antigen testing. Those who are positive will receive a 14-day antibiotic treatment (levofloxacin-based therapy) to eradicate the infection. Platelet counts will be measured before and after therapy to determine whether successful eradication improves platelet levels.
The findings from this study may help provide new treatment options for ITP patients and give doctors in Iraq more evidence about how H. pylori infection affects blood disorders.
Read the detailed description
Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelet counts and increased bleeding risk. Several studies have suggested a link between Helicobacter pylori infection and platelet recovery following eradication therapy, though results differ across regions and populations.
This investigator-initiated, prospective study aims to assess the hematological effect of H. pylori eradication in Iraqi patients with ITP. A total of 100 patients will be recruited at two hematology centers in Baghdad. Patients will undergo stool antigen testing to determine H. pylori status.
The study is divided into two phases:
Phase 1: Observational cross-sectional analysis of ITP patients who are H. pylori negative.
Phase 2: Interventional, prospective, open-label evaluation of ITP patients who are H. pylori positive compared with H. pylori negative controls.
Patients testing positive for H. pylori will receive a 14-day levofloxacin-based triple therapy regimen consistent with current American College of Gastroenterology (ACG) guidelines. Platelet counts will be measured at baseline and four weeks after therapy completion. Outcomes will focus on hematological response to eradication, with secondary analysis comparing platelet recovery between H. pylori positive and negative patients.
This study is the first in Iraq to evaluate the impact of salvage therapy for H. pylori eradication in ITP patients. The results may provide novel insights into regional differences in treatment response and inform future clinical practice guidelines for managing ITP.
- Being tested
- Levofloxacin-Based H. pylori Eradication Therapy
- Keywords
- immune thrombocytopenia, ITP, Helicobacter pylori, H.pylori, Levofloxacin-based Triple Therapy, Salvage Therapy, Hematology, Iraq
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin-Based H. pylori Eradication TherapyDrug
This intervention consists of a 14-day levofloxacin-based triple therapy regimen for Helicobacter pylori eradication in ITP patients. The regimen follows current ACG guidelines and typically includes:
Levofloxacin - antibiotic targeting H. pylori
Amoxicillin - antibiotic used in combination for enhanced efficacy
Proton Pump Inhibitor (PPI) - to reduce stomach acid and improve antibiotic effectiveness
Patients will receive the full 14-day course, and platelet counts will be measured at baseline and four weeks post-therapy to assess hematological response. This intervention is unique to H. pylori-positive ITP patients in this study and is not administered to H. pylori-negative patients.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori-Positive ITP Patients - Eradication Therapy | Experimental | Patients who test positive for Helicobacter pylori will receive a 14-day levofloxacin-based triple therapy regimen according to ACG guidelines. Platelet counts will be measured at baseline and four weeks after completion of therapy to assess hematological response. Receives: Drug: Levofloxacin-Based H. pylori Eradication Therapy |
| H. pylori-Negative ITP Patients - No Therapy | No intervention | Patients who test negative for H. pylori will not receive eradication therapy. Platelet counts will be monitored at the same time points as the intervention group to serve as a comparison for evaluating treatment effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet Count After H. pylori Eradication
The primary outcome is the absolute change in platelet count (×10⁹/L) from baseline to four weeks after completion of levofloxacin-based H. pylori eradication therapy in H. pylori-positive ITP patients. Platelet counts will be measured using standard hematology analyzers (Hemmary 86 and Cellagon 5 Pro).
Measured: Baseline and 4 weeks post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2024
- Primary completion31 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group study. Patients with ITP who test positive for H. pylori receive a 14-day levofloxacin-based eradication regimen, while H. pylori-negative ITP patients serve as the comparison group without eradication therapy. Platelet counts are monitored before and after treatment to assess hematological response.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murtadha Al-Owayef, Al-Mustansiriyah University
- Investigators
- Manal Khalid Abdulridha, proffessor at Mustansiriyah, Principal investigator, Al-Mustansiriyah University - National Center of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150286
- Sponsor's protocol ID
- 96
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hematological Effect of H.Pylori and H.Pylori Eradication Therapy Among a Sample of Iraqi ITP Patients
- ClinicalTrials.gov ID
- NCT07150286
- Acronym / sponsor ID
- 96
- Keywords
- immune thrombocytopenia, ITP, Helicobacter pylori, H.pylori, Levofloxacin-based Triple Therapy, Salvage Therapy, Hematology, Iraq
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 2 Sep 2025 (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 being conducted to evaluate the effect of treating Helicobacter pylori infection on platelet counts in patients with immune thrombocytopenia (ITP). ITP is a condition in which the body's immune system attacks its own platelets, leading to an increased risk of bleeding and bruising. Some studies have suggested that removing H. pylori infection may help improve platelet counts in certain patients with ITP.
In this study, 100 patients with ITP will be enrolled at hematology centers in Baghdad. Patients will be tested for H. pylori infection using stool antigen testing. Those who are positive will receive a 14-day antibiotic treatment (levofloxacin-based therapy) to eradicate the infection. Platelet counts will be measured before and after therapy to determine whether successful eradication improves platelet levels.
The findings from this study may help provide new treatment options for ITP patients and give doctors in Iraq more evidence about how H. pylori infection affects blood disorders.
Detailed description
Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelet counts and increased bleeding risk. Several studies have suggested a link between Helicobacter pylori infection and platelet recovery following eradication therapy, though results differ across regions and populations.
This investigator-initiated, prospective study aims to assess the hematological effect of H. pylori eradication in Iraqi patients with ITP. A total of 100 patients will be recruited at two hematology centers in Baghdad. Patients will undergo stool antigen testing to determine H. pylori status.
The study is divided into two phases:
Phase 1: Observational cross-sectional analysis of ITP patients who are H. pylori negative.
Phase 2: Interventional, prospective, open-label evaluation of ITP patients who are H. pylori positive compared with H. pylori negative controls.
Patients testing positive for H. pylori will receive a 14-day levofloxacin-based triple therapy regimen consistent with current American College of Gastroenterology (ACG) guidelines. Platelet counts will be measured at baseline and four weeks after therapy completion. Outcomes will focus on hematological response to eradication, with secondary analysis comparing platelet recovery between H. pylori positive and negative patients.
This study is the first in Iraq to evaluate the impact of salvage therapy for H. pylori eradication in ITP patients. The results may provide novel insights into regional differences in treatment response and inform future clinical practice guidelines for managing ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group study. Patients with ITP who test positive for H. pylori receive a 14-day levofloxacin-based eradication regimen, while H. pylori-negative ITP patients serve as the comparison group without eradication therapy. Platelet counts are monitored before and after treatment to assess hematological response.
| Arm | Type | Receives |
|---|---|---|
| H. pylori-Positive ITP Patients - Eradication Therapy | Experimental | Drug: Levofloxacin-Based H. pylori Eradication TherapyPatients who test positive for Helicobacter pylori will receive a 14-day levofloxacin-based triple therapy regimen according to ACG guidelines. Platelet counts will be measured at baseline and four weeks after completion of therapy to assess hematological response. |
| H. pylori-Negative ITP Patients - No Therapy | No intervention | –Patients who test negative for H. pylori will not receive eradication therapy. Platelet counts will be monitored at the same time points as the intervention group to serve as a comparison for evaluating treatment effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years) with a confirmed diagnosis of ITP Platelet count <100,000/µL. H. pylori-positive or H. pylori-negative based on stool antigen test
Key exclusion criteria (7 listed)
- • Patients with other causes of thrombocytopenia (e.g., leukemia, aplastic anemia).
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 |
|---|---|---|
| Levofloxacin-Based H. pylori Eradication TherapyThis intervention consists of a 14-day levofloxacin-based triple therapy regimen for Helicobacter pylori eradication in ITP patients. The regimen follows current ACG guidelines and typically includes: Levofloxacin - antibiotic targeting H. pylori Amoxicillin - antibiotic used in combination for enhanced efficacy Proton Pump Inhibitor (PPI) - to reduce stomach acid and improve antibiotic effectiveness Patients will receive the full 14-day course, and platelet counts will be measured at baseline and four weeks post-therapy to assess hematological response. This intervention is unique to H. pylori-positive ITP patients in this study and is not administered to H. pylori-negative patients. | Drug | H. pylori-Positive ITP Patients - Eradication Therapy |
Primary outcome
Change in Platelet Count After H. pylori Eradication
Time frame: Baseline and 4 weeks post-therapy
The primary outcome is the absolute change in platelet count (×10⁹/L) from baseline to four weeks after completion of levofloxacin-based H. pylori eradication therapy in H. pylori-positive ITP patients. Platelet counts will be measured using standard hematology analyzers (Hemmary 86 and Cellagon 5 Pro).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Manal Khalid Abdulridha, proffessor at Mustansiriyah principal investigator
Al-Mustansiriyah University - National Center of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin-Based H. pylori Eradication Therapy in people with Immune Thrombocytopenic Purpura and HELICOBACTER PYLORI INFECTIONS, run by Al-Mustansiriyah University at 1 site in Iraq.
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 7 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 Iraq. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Platelet Count After H. pylori Eradication (time frame: Baseline and 4 weeks post-therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.