Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05927766

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Device: esophagogastroduodenoscopy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: patients with chronic kidney disease	Device: esophagogastroduodenoscopy patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated
Active Comparator: patients without chronic kidneys disease	Device: esophagogastroduodenoscopy patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated

Arm

Intervention/Treatment

Active Comparator: patients with chronic kidney disease

Device: esophagogastroduodenoscopy

patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated

Active Comparator: patients without chronic kidneys disease

Device: esophagogastroduodenoscopy

patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated

Outcome Measures

Primary Outcome Measures

Description the gastroduodenal lesions found in upper endoscopy in patients with chronic kidney disease or not and correlate them to helicobacter pylori infection [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag university hospital	Sohag		Egypt

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Usama a arafa, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Faisal Abdellah, Principal investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT05927766

Other Study ID Numbers:

CKD and H.Pylori infection

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 3, 2023