Chronic Kidney DiseasesNCT06371001
Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical Complex
An observational study of Chronic Kidney Diseases, run by Assiut University.
Trial summary
Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- disease
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jul 2025
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical complex hospital
Who may be able to join
- All patients aged >18 years old with chronic kidney disease of different etiology based on clinical examination, laboratory investigations and imaging
Who cannot join
- Patients aged ≤18 years old.
- Overloaded patients
- patient with acute kidney injury
- Patients with other GIT disease
- pregnant female
- patient taking aspirin, NSAID, steroid or antibiotic
- Presence of malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical
Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology
Read the detailed description
Helicobacter Pylori bacteria is the main pathogenic organism that settles on the gastric mucosa of more than half the human population around the world, with more prominence in the developing countries. H. Pylori had been found to be the main factor in acute and chronic gastritis, peptic ulcer diseases, and in most cases gastric malignancy. Beside to some extra gastro-intestinal diseases. Such as cardiac, pulmonary, renal and hematological diseases.
Another study showed a significant higher proteinuria in H. Pylori infected patients compared to non-infected individuals. Helicobacter pylori is a gram-negative bacterium infecting both children and adults. It is the most common human chronic infection, causing gastrointestinal diseases such as gastric malignancies, gastritis, and ulcerative diseases. H. pylori can also be involved in other non gastrointestinal infections such as diabetes and metabolic syndrome, heart disease, hematologic disorders, cancer, and chronic kidney disease (CKD) as well as chronic renal failure (CRF).
Some chronic renal failure patients who have received hemodialysis for long periods complained of gastrointestinal troubles. It has been postulated that high urea concentration makes the gastric mucosa of these patients more susceptible to H. pylori colonization. Previous observations in different countries reported the prevalence of H. pylori infection among patients with CRF ranging between 20 and 60%, and H. pylori infection can contribute to progressive renal dysfunction resulting in CKD development. In patients without established gastric dysfunction, the presence of H pylori infection was associated with increased risk for Chronic kidney dusease however, patients with both atrophic gastritis (AG) and Helcobacter pylori infection appeared to be at decreased risk for Chronic kidney disease compared with control participants.
For the H. pylori-positive patients with peptic ulcer, H. pylori infection may be a risk factor resulting in kidney damage and H. pylori eradication probably benefits to kidney damage relief and chronic kidney disease prevention.
- Conditions
- Chronic Kidney Diseases
- Being tested
- disease
- 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.
diseaseOther
Helicobacter Pylori Infection In Chonic Kidney Diseased Patien
| Study group | Role | What they receive |
|---|---|---|
| prevalence of helicobacter pylori in chronic kidney diseased patient | prevalence of helicobacter pylori in chronic kidney diseased patient Receives: Other: disease | |
| prevalence of helicobacter pylori in non chronic kidney diseased patient | prevalence of helicobacter pylori in non chronic kidney diseased patient Receives: Other: disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori infection and Chronic kidney diseased patient
Detect prevalence of H pylori infection in chronic kidney diseased patient admitted to Luxor medical complex hospital
Measured: 1 year
Secondary outcomes (1)
possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology
possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Abdel Shafy Ahmed Abdel kader, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371001
- Sponsor's protocol ID
- Helicobacter Pyloi and CKD
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin SP, Bang CS, Lee JJ, Baik GH. Helicobacter pylori Infection in Patients with Chronic Kidney Disease: A Systematic Review and Meta-Analysis. Gut Liver. 2019 Nov 15;13(6):628-641. doi: 10.5009/gnl18517.
PubMed 30970438Zizzi CF, Pellicano R, Biancone L. The relationship between Helicobacter pylori and chronic kidney disease: update 2020. Minerva Gastroenterol Dietol. 2020 Dec;66(4):343-349. doi: 10.23736/S1121-421X.20.02729-4. Epub 2020 Jul 3.
PubMed 32623870Hata K, Koyama T, Ozaki E, Kuriyama N, Mizuno S, Matsui D, Watanabe I, Uehara R, Watanabe Y. Assessing the Relationship between Helicobacter pylori and Chronic Kidney Disease. Healthcare (Basel). 2021 Feb 3;9(2):162. doi: 10.3390/healthcare9020162.
PubMed 33546229Lin SY, Lin CL, Liu JH, Yang YF, Huang CC, Kao CH. Association between Helicobacter pylori infection and the subsequent risk of end-stage renal disease: a nationwide population-based cohort study. Int J Clin Pract. 2015 May;69(5):604-10. doi: 10.1111/ijcp.12602. Epub 2015 Jan 21.
PubMed 25644865
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical
- ClinicalTrials.gov ID
- NCT06371001
- Acronym / sponsor ID
- Helicobacter Pyloi and CKD
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology
Detailed description
Helicobacter Pylori bacteria is the main pathogenic organism that settles on the gastric mucosa of more than half the human population around the world, with more prominence in the developing countries. H. Pylori had been found to be the main factor in acute and chronic gastritis, peptic ulcer diseases, and in most cases gastric malignancy. Beside to some extra gastro-intestinal diseases. Such as cardiac, pulmonary, renal and hematological diseases.
Another study showed a significant higher proteinuria in H. Pylori infected patients compared to non-infected individuals. Helicobacter pylori is a gram-negative bacterium infecting both children and adults. It is the most common human chronic infection, causing gastrointestinal diseases such as gastric malignancies, gastritis, and ulcerative diseases. H. pylori can also be involved in other non gastrointestinal infections such as diabetes and metabolic syndrome, heart disease, hematologic disorders, cancer, and chronic kidney disease (CKD) as well as chronic renal failure (CRF).
Some chronic renal failure patients who have received hemodialysis for long periods complained of gastrointestinal troubles. It has been postulated that high urea concentration makes the gastric mucosa of these patients more susceptible to H. pylori colonization. Previous observations in different countries reported the prevalence of H. pylori infection among patients with CRF ranging between 20 and 60%, and H. pylori infection can contribute to progressive renal dysfunction resulting in CKD development. In patients without established gastric dysfunction, the presence of H pylori infection was associated with increased risk for Chronic kidney dusease however, patients with both atrophic gastritis (AG) and Helcobacter pylori infection appeared to be at decreased risk for Chronic kidney disease compared with control participants.
For the H. pylori-positive patients with peptic ulcer, H. pylori infection may be a risk factor resulting in kidney damage and H. pylori eradication probably benefits to kidney damage relief and chronic kidney disease prevention.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prevalence of helicobacter pylori in chronic kidney diseased patient | – | Other: diseaseprevalence of helicobacter pylori in chronic kidney diseased patient |
| prevalence of helicobacter pylori in non chronic kidney diseased patient | – | Other: diseaseprevalence of helicobacter pylori in non chronic kidney diseased patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical complex hospital
Key inclusion criteria (1 listed)
- All patients aged >18 years old with chronic kidney disease of different etiology based on clinical examination, laboratory investigations and imaging
Key exclusion criteria (7 listed)
- Patients aged ≤18 years old.
- Overloaded patients
- patient with acute kidney injury
- Patients with other GIT disease
- pregnant female
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 |
|---|---|---|
| diseaseHelicobacter Pylori Infection In Chonic Kidney Diseased Patien | Other | prevalence of helicobacter pylori in chronic kidney diseased patient, prevalence of helicobacter pylori in non chronic kidney diseased patient |
Primary outcome
Helicobacter pylori infection and Chronic kidney diseased patient
Time frame: 1 year
Detect prevalence of H pylori infection in chronic kidney diseased patient admitted to Luxor medical complex hospital
1 secondary outcome
possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 30970438Shin SP, Bang CS, Lee JJ, Baik GH. Helicobacter pylori Infection in Patients with Chronic Kidney Disease: A Systematic Review and Meta-Analysis. Gut Liver. 2019 Nov 15;13(6):628-641. doi: 10.5009/gnl18517.
- Background: PubMed 32623870Zizzi CF, Pellicano R, Biancone L. The relationship between Helicobacter pylori and chronic kidney disease: update 2020. Minerva Gastroenterol Dietol. 2020 Dec;66(4):343-349. doi: 10.23736/S1121-421X.20.02729-4. Epub 2020 Jul 3.
- Background: PubMed 33546229Hata K, Koyama T, Ozaki E, Kuriyama N, Mizuno S, Matsui D, Watanabe I, Uehara R, Watanabe Y. Assessing the Relationship between Helicobacter pylori and Chronic Kidney Disease. Healthcare (Basel). 2021 Feb 3;9(2):162. doi: 10.3390/healthcare9020162.
- Background: PubMed 25644865Lin SY, Lin CL, Liu JH, Yang YF, Huang CC, Kao CH. Association between Helicobacter pylori infection and the subsequent risk of end-stage renal disease: a nationwide population-based cohort study. Int J Clin Pract. 2015 May;69(5):604-10. doi: 10.1111/ijcp.12602. Epub 2015 Jan 21.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Assiut University.
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 1 inclusion and 7 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Gehad Abdel shafy, Resident (01125577928, gehadabdelshafy980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori infection and Chronic kidney diseased patient (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371001, which also lists 4 linked publications.
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 17 Apr 2024.