Chronic Kidney DiseasesNCT05927766
Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
A study testing esophagogastroduodenoscopy in people with Chronic Kidney Diseases, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- esophagogastroduodenoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- frail patients with multiple comorbidities or malignant disease.
- pregnant ladies.
- patients recently on proton pump inhibitors two weeks or less prior to the interview.
Trial locations and contacts
1 site in 1 country.
Ahmed n nour eldeen contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
magdy m ameen, prof
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- esophagogastroduodenoscopy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagogastroduodenoscopyDevice
patients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic kidney disease | Active comparator | Not described Receives: Device: esophagogastroduodenoscopy |
| patients without chronic kidneys disease | Active comparator | Not described Receives: Device: esophagogastroduodenoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description the gastroduodenal lesions found in upper endoscopy in patients with chronic kidney disease or not and correlate them to helicobacter pylori infection
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faisal Abdellah, Sohag University
- Investigators
- Usama a arafa, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927766
- Sponsor's protocol ID
- CKD and H.Pylori infection
- Status last verified
- Jun 2023
- First submitted
- 12 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Endoscopic Findings And Helicobacter Pylori Infection In Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05927766
- Acronym / sponsor ID
- CKD and H.Pylori infection
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with chronic kidney disease | Active comparator | Device: esophagogastroduodenoscopy |
| patients without chronic kidneys disease | Active comparator | Device: esophagogastroduodenoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- frail patients with multiple comorbidities or malignant disease.
- pregnant ladies.
- patients recently on proton pump inhibitors two weeks or less prior to the interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagogastroduodenoscopypatients with upper gastrointestinal symptoms will gone to upper endoscopy and biopsy when indicated | Device | patients with chronic kidney disease, patients without chronic kidneys disease |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed n nour eldeen contact
Usama a arafa study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagogastroduodenoscopy in people with Chronic Kidney Diseases, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed f ebdalla, dr (01062271010, mohamedfaisel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.