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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05927766
Recruitment Status : Recruiting
First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Faisal Abdellah, Sohag University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Device: esophagogastroduodenoscopy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05927766


Contacts
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Contact: mohamed f ebdalla, dr 01062271010 mohamedfaisel@med.sohag.edu.eg
Contact: Ahmed n nour eldeen 01127022717

Locations
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Egypt
Sohag university hospital Recruiting
Sohag, Egypt
Contact: magdy m ameen, prof         
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Usama a arafa Sohag University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mohamed Faisal Abdellah, Principal investigator, Sohag University
ClinicalTrials.gov Identifier: NCT05927766    
Other Study ID Numbers: CKD and H.Pylori infection
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes