Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
esophagogastroduodenoscopy
Sponsored by
About this trial
This is an interventional screening trial for Chronic Kidney Diseases
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.
Sites / Locations
- Sohag university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patients with chronic kidney disease
patients without chronic kidneys disease
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05927766
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with chronic kidney disease
Arm Type
Active Comparator
Arm Title
patients without chronic kidneys disease
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
esophagogastroduodenoscopy
Intervention Description
patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated
Primary Outcome Measure Information:
Title
Description the gastroduodenal lesions found in upper endoscopy in patients with chronic kidney disease or not and correlate them to helicobacter pylori infection
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed f ebdalla, dr
Phone
01062271010
Email
mohamedfaisel@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed n nour eldeen
Phone
01127022717
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama a arafa
Organizational Affiliation
Sohag University
Official's Role
Study Director
Facility Information:
Facility Name
Sohag university hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m ameen, prof
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
We'll reach out to this number within 24 hrs