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H.Pylori InfectionNCT05882968

Prevalence of H.Pylori in CKD Patients

An observational study of H.Pylori Infection, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Essam eldeen Abd elmohsen contact

0100 197 1906

essam-223@yahoo.com

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.

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 groups in NCT05882968
Study groupRoleWhat they receive
H. Pylori in CKD patients100 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 function100 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.

  1. 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.

  1. First posted31 May 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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)
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

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.

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