Prevalence of H.Pylori in CKD Patients

NCT ID: NCT05882968

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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H.Pylori Infection

Keywords

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CKd patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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H. Pylori in CKD patients

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

kidney function tests

Intervention Type DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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kidney function tests

using GFR test according to kdigo guide lines

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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hanaa zakaria william

resident of nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abd elhamid Mohammed

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Hanaa Zakaria

Role: CONTACT

Phone: 01033721014

Email: [email protected]

Essam eldeen Abd elmohsen

Role: CONTACT

Phone: 0100 197 1906

Email: [email protected]

Other Identifiers

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H.pylori in CKD patients

Identifier Type: -

Identifier Source: org_study_id