Prevalence of H.Pylori in CKD Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05882968
Collaborator
(none)
200
26.1

Study Details

Study Description

Brief 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.
Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: kidney function tests

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Helicobacter Pylori in Chronic Kidney Diseases in Assiut University Hospitals
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
H. Pylori in CKD patients

100 0f patients with H.pylori with ckd according to GFR more than 60 according to kdigo guide lines

Diagnostic Test: kidney function tests
using GFR test 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

Outcome Measures

Primary Outcome Measures

  1. Relationship between H.pylori and CKD patients according to Glomural filtration rate (GFR )according to kdigo guide lines [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Abd elhamid Mohammed, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hanaa zakaria william, resident of nephrology, Assiut University
ClinicalTrials.gov Identifier:
NCT05882968
Other Study ID Numbers:
  • H.pylori in CKD patients
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hanaa zakaria william, resident of nephrology, Assiut University

Study Results

No Results Posted as of May 31, 2023