H.Pylori InfectionNCT05882968
Prevalence of H.Pylori in CKD Patients
An observational study of H.Pylori Infection, run by Assiut University.
Trial summary
The study aims to:- Investigate the relationship between H. pylori and CKD, in order to determine whether an association exists between H.pylori and kidneys. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- H.Pylori Infection
- What is being tested?
- kidney function tests
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to Sep 2025
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 200 of patients with H. pylori 100 of them with ckd 100 of them with normal renal function
Who may be able to join
- Patients age >18 -65 years.
- 100 of them are CKd with GFR less than 60 according to kdigo guidelines
- 100 of them are normal renal function with GFR more than 60 according to kdigo guidelines
Who cannot join
- • H-pylori eradication
- History of gastrectomy
- Used proton-pump inhibitor. Patients with Past or present history of malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Helicobacter Pylori in Chronic Kidney Diseases in Assiut University Hospitals
The study aims to:-
- Investigate the relationship between H. pylori and CKD, in order to determine whether an association exists between H.pylori and kidneys.
Read the detailed description
Helicobacter pylori is a spiral-shaped, gram-negative flagellated bacterium that usually resides in the gastric mucosa [1]. It affects approximately 50% of the world's population, even 80% in lower and middle outcome countries [1] [2].
The prevalence according to a study conducted by Ankouane et al. in Yaoundé (Cameroon) is up to 72.5% in hospital [3]. The main route of transmission is person to person transmission and often occurs in the first 5 years of life [4].
Helicobacter pylori is the most common human chronic infection, causing gastrointestinal diseases such as gastric malignancies, gastritis, and ulcerative diseases. H. pylori can also be involved in other non-gastrointestinal infections such as diabetes and metabolic syndrome, heart disease, hematologic disorders, cancer, and chronic kidney disease (CKD) as well as chronic renal failure (CRF) [5].
The risk factors for infection with H. pylori are low socioeconomic level, promiscuity, family history of H. pylori infection or gastritis, alcohol consumption, smoking [6].
The stomach is reported to be associated with conditions affecting other organs. Such as, an association between atrophic gastritis (AG) and coronary artery disease has been described, with AG representing a potential independent risk factor for coronary artery disease [7].
The diagnosis of H. pylori is made by noninvasive methods (the rapid urease test, the breath test, serology, stool antigen test) or invasive methods biopsy-based tests (culture and histology) [8]. The gold standard is histology, but current methods have been developed, using high-definition endoscopy [9].
Chronic kidney disease (CKD) is a growing disease and public health problem worldwide [10]. Gastrointestinal (GI) symptoms are common among subjects with CKD, and their intensity vary slightly to very severe, altering the quality of life and potentially hindering the effectiveness of the treatment [11] and also affects their nutrition status leading to the development of malnutrition, which is a potent predictor of morbidity and mortality [12].
Patients with chronic renal failure (CRF) often have gastrointestinal symptoms caused not only by H. pylori infection, but also by high urea levels, decline of gastrointestinal motility, hypergastrinemia and high ammonia levels [10-13].
Moreover, patients with CRF may have higher risks of gastric mucosal damages compared with individuals with normal renal function because of systemic and/or local chronic circulatory failure [14].
Epidemiological studies have revealed a link between H. pylori with insulin resistance and metabolic syndrome , which may increase the risk of CKD. However, up to date there is no conclusive evidence regarding the association between H. pylori infection and CKD [15].
A previous study reported that individuals infected with H. pylori had a higher risk of subsequent renal dysfunction than those not infected [12]. Conversely, the H. pylori infection rate is lower in patients with peptic ulcer disease and concomitant chronic kidney disease (CKD) than in those without CKD [13]. However, the relationship between H. pylori infection and/or gastric disorders and CKD has not been elucidated.
- Conditions
- H.Pylori Infection
- Being tested
- kidney function tests
- Keywords
- CKd patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney function testsDiagnostic test
using GFR test according to kdigo guide lines
| Study group | Role | What they receive |
|---|---|---|
| H. Pylori in CKD patients | 100 0f patients with H.pylori with ckd according to GFR more than 60 according to kdigo guide lines Receives: Diagnostic Test: kidney function tests | |
| H.pylori in normal renal function | 100 of patients with H.pylori with normal renal function according to GFR less than 60 according to kdigo guide lines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between H.pylori and CKD patients according to Glomural filtration rate (GFR )according to kdigo guide lines
To assess if H pylori with CKd patients more than H pylori in normal renal function patients or not that aging 18_65 years
Measured: july 2023 to july 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanaa zakaria william, Assiut University
- Investigators
- Abd elhamid Mohammed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882968
- Sponsor's protocol ID
- H.pylori in CKD patients
- Status last verified
- May 2023
- First submitted
- 14 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Helicobacter Pylori in Chronic Kidney Diseases in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05882968
- Acronym / sponsor ID
- H.pylori in CKD patients
- Conditions
- H.Pylori Infection
- Keywords
- CKd patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 31 May 2023 (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.
The study aims to:-
- Investigate the relationship between H. pylori and CKD, in order to determine whether an association exists between H.pylori and kidneys.
Detailed description
Helicobacter pylori is a spiral-shaped, gram-negative flagellated bacterium that usually resides in the gastric mucosa [1]. It affects approximately 50% of the world's population, even 80% in lower and middle outcome countries [1] [2].
The prevalence according to a study conducted by Ankouane et al. in Yaoundé (Cameroon) is up to 72.5% in hospital [3]. The main route of transmission is person to person transmission and often occurs in the first 5 years of life [4].
Helicobacter pylori is the most common human chronic infection, causing gastrointestinal diseases such as gastric malignancies, gastritis, and ulcerative diseases. H. pylori can also be involved in other non-gastrointestinal infections such as diabetes and metabolic syndrome, heart disease, hematologic disorders, cancer, and chronic kidney disease (CKD) as well as chronic renal failure (CRF) [5].
The risk factors for infection with H. pylori are low socioeconomic level, promiscuity, family history of H. pylori infection or gastritis, alcohol consumption, smoking [6].
The stomach is reported to be associated with conditions affecting other organs. Such as, an association between atrophic gastritis (AG) and coronary artery disease has been described, with AG representing a potential independent risk factor for coronary artery disease [7].
The diagnosis of H. pylori is made by noninvasive methods (the rapid urease test, the breath test, serology, stool antigen test) or invasive methods biopsy-based tests (culture and histology) [8]. The gold standard is histology, but current methods have been developed, using high-definition endoscopy [9].
Chronic kidney disease (CKD) is a growing disease and public health problem worldwide [10]. Gastrointestinal (GI) symptoms are common among subjects with CKD, and their intensity vary slightly to very severe, altering the quality of life and potentially hindering the effectiveness of the treatment [11] and also affects their nutrition status leading to the development of malnutrition, which is a potent predictor of morbidity and mortality [12].
Patients with chronic renal failure (CRF) often have gastrointestinal symptoms caused not only by H. pylori infection, but also by high urea levels, decline of gastrointestinal motility, hypergastrinemia and high ammonia levels [10-13].
Moreover, patients with CRF may have higher risks of gastric mucosal damages compared with individuals with normal renal function because of systemic and/or local chronic circulatory failure [14].
Epidemiological studies have revealed a link between H. pylori with insulin resistance and metabolic syndrome , which may increase the risk of CKD. However, up to date there is no conclusive evidence regarding the association between H. pylori infection and CKD [15].
A previous study reported that individuals infected with H. pylori had a higher risk of subsequent renal dysfunction than those not infected [12]. Conversely, the H. pylori infection rate is lower in patients with peptic ulcer disease and concomitant chronic kidney disease (CKD) than in those without CKD [13]. However, the relationship between H. pylori infection and/or gastric disorders and CKD has not been elucidated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H. Pylori in CKD patients | – | Diagnostic Test: kidney function tests100 0f patients with H.pylori with ckd according to GFR more than 60 according to kdigo guide lines |
| H.pylori in normal renal function | – | –100 of patients with H.pylori with normal renal function according to GFR less than 60 according to kdigo guide lines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 200 of patients with H. pylori 100 of them with ckd 100 of them with normal renal function
Key inclusion criteria (3 listed)
- Patients age >18 -65 years.
Key exclusion criteria (3 listed)
- • H-pylori eradication
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 |
|---|---|---|
| kidney function testsusing GFR test according to kdigo guide lines | Diagnostic test | H. Pylori in CKD patients |
Primary outcome
Relationship between H.pylori and CKD patients according to Glomural filtration rate (GFR )according to kdigo guide lines
Time frame: july 2023 to july 2025
To assess if H pylori with CKd patients more than H pylori in normal renal function patients or not that aging 18_65 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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.
Abd elhamid Mohammed study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of H.Pylori Infection, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanaa Zakaria (01033721014, hanaazakaria30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between H.pylori and CKD patients according to Glomural filtration rate (GFR )according to kdigo guide lines (time frame: july 2023 to july 2025). 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 31 May 2023.