NCT05927766

Brief Summary

The aim of this study is to

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

May 12, 2023

Last Update Submit

June 25, 2023

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients with chronic kidney disease

ACTIVE COMPARATOR
Device: esophagogastroduodenoscopy

patients without chronic kidneys disease

ACTIVE COMPARATOR
Device: esophagogastroduodenoscopy

Interventions

esophagogastroduodenoscopyDEVICE

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

patients with chronic kidney diseasepatients without chronic kidneys disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Usama a arafa

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

mohamed f ebdalla, dr

CONTACT

01062271010mohamedfaisel@med.sohag.edu.eg

Ahmed n nour eldeen

CONTACT

01127022717

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 12, 2023

First Posted

July 3, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

EG(1)