Clinical trial NCT05927766: Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
Official title: Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: The aim of this study is to

1. Evaluate frequency of H. pylori infection in patients with CKD.
2. Description the gastroduodenal lesions found in patients with chronic kidney disease and correlate it to H.pylori infection.

Detailed description: cross sectional study to study the relationship between Helicobacter Pylori Infection and Gastroduodenal Lesions in Patients with Chronic Kidney Disease, There have been some debates about the association of Helicobacter pylori infection and chronic kidney disease (CKD). Pathogenesis of H. pylori infection in patients with CKD is not clearly revealed and there are not enough studies about these two factors.

There are several hypothesis which support that kidney disease may reduce H. pylori infection. High level of serum urea nitrogen can contribute to a decreased gastric acid secretion and higher gastric alkalosis which could be the cause of lower prevalence of H. pylori among CKD. Inflammatory cytokines are also increased in CKD patients and it can cause gastric mucosal damage, chronic gastritis, and spontaneously eradicate H. pylori. In addition, antibiotics, proton pump inhibitors, or H2 receptor antagonists which are used in patients with CKD for long time might be associated with decreased H. pylori infection.

There are other hypothesis that are contrary to above theories. Some studies showed that high u rea concentration makes the gastric mucosa more susceptible to H. pylori and infection rate is higher in uremic patients. And, in some articles which have studied about peptic ulcer in CKD, the prevalence of H. pylori infection looked lower compare to ulcer in non-CKD patients but real incidence may not be lower. Because the incidence of peptic ulcer is higher in CKD patients with various causes except H. pylori infection.

Gastrointestinal (GI) disorders are the most prevalent chronic problem in CKD patients, ranking second in frequency only to renal failure itself. GI disorders affect 70 to 80% of patients on Hemodialysis (HD); yet, little is known about the impact of Hp infection on this multifactorial disorder.

Eligibility criteria: Inclusion Criteria:

* Patients with CKD classified as stages 3 to 5 according Kidney Disease Improving Global Outcomes classification, on hemodialysis or not.
* control group without chronic kidney disease.

Exclusion Criteria:

* frail patients with multiple comorbidities or malignant disease.
* pregnant ladies.
* patients recently on proton pump inhibitors two weeks or less prior to the interview.

Primary outcomes:
measure: Description the gastroduodenal lesions found in upper endoscopy in patients with chronic kidney disease or not and correlate them to helicobacter pylori infection
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
affiliation: Sohag University
name: Usama a arafa
role: STUDY_DIRECTOR
References: