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Prevalence of H.Pylori in CKD Patients

A

Assiut University

Status

Not yet enrolling

Conditions

H.Pylori Infection

Treatments

Diagnostic Test: kidney function tests

Study type

Observational

Funder types

Other

Identifiers

NCT05882968
H.pylori in CKD patients

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • • H-pylori eradication

    • History of gastrectomy
    • Used proton-pump inhibitor. Patients with Past or present history of malignancy

Trial design

200 participants in 2 patient groups

H. Pylori in CKD patients
Description:
100 0f patients with H.pylori with ckd according to GFR more than 60 according to kdigo guide lines
Treatment:
Diagnostic Test: kidney function tests
H.pylori in normal renal function
Description:
100 of patients with H.pylori with normal renal function according to GFR less than 60 according to kdigo guide lines

Trial contacts and locations

0

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Central trial contact

Essam eldeen Abd elmohsen; Hanaa Zakaria

Data sourced from clinicaltrials.gov

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