Helicobacter Pylori InfectionNCT03310255
Helicobacter Pylori Infection in Renal Transplant Patients
An observational study of Helicobacter Pylori Infection and Renal Transplant Infection, run by Assiut University.
Trial summary
Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection, Renal Transplant Infection
- What is being tested?
- H pylori Faecal Antigen
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 28 Feb 2019
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Post renal transplant patients, and patients proven to be h pylori positive will be subjected to further evaluation.
Who may be able to join
- Age ≥ 18 years.
- Patients in the first 1st. year after kidney transplantation.
- Patients diagnosed to have H.pylori infection by H.pylori fecal Ag will do endoscopy and biopsy.
Who cannot join
- Patients who had previous upper endoscopy with evidence of gastritis or ulcers
- Age more than 65 years old
- Patients with any contraindications to upper endoscopy.
Trial locations and contacts
No sites are listed yet.
About this study
Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and because these drugs have many side effects that may not be differentiated from H. pylori infection Thus, in order to reduce the use of medications and subsequently to reduce the drug interactions ,proper detection and management of H pylori infection in those patients is preferred.
Read the detailed description
The prevalence of HP colonization is about 30% in the United States and other developed countries as opposed to more than 80% in most developing countries.
Essentially, all HP-colonized persons have gastric inflammation, but this condition in itself is asymptomatic.
Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal.
GI complications might require dose reduction or the discontinuation of some of the immunosuppressive medications, affecting graft survival.
Considering the strong body of evidence supporting causal effects of HP infections on the development of peptic ulcers and gastric malignancies, the argumented rate of gastrointestinal complaints may bebattributed to increased HP infection rate among this population.
Few studies have investigated the prevalence of HP infection; about 30% to 40% of renal transplant recipients shown HP colonization of the stomach There are conflicting data about the prevalence of H pylori infection in renal transplant recipients. Most of these studies used anti HP IgG to diagnose H. pylori infection that lack consistent sensitivity and specificity.
Nasri and his colleagues in 2013 concluded significant positive association of serum H. Pylori IgG antibody titer with renal function in renal transplant patient.
As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and because these drugs have many side effects that may not be differentiated from H. pylori infection Thus, in order to reduce the use of medications and subsequently to reduce the drug interactions ,proper detection and management of H pylori infection in those patients is preferred.
There are few studies have investigated the prevalence of HP infection; about 30% to 40% of renal transplant recipients shown HP colonization of the stomach. There are conflicting data about the prevalence of H pylori infection in renal transplant recipients.
- Being tested
- H pylori Faecal Antigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H pylori Faecal AntigenDiagnostic test
Also called Endoscopic Biopsy and culture, PCR
All patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of H pylori post Renal Transplant Patients
Percentage of H pylori positive patients in post renal transplant patients
Measured: 1 year
Detection of CagA & VacA Genotypes by PCR:
Amplified DNA will be analyzed by agarose gel electrophoresis. The positive sample will produce bands at DNA fragment 138-bp for CagA, 259/286-bp for VacA S1/S2, 290-bp and 352-bp for m1 \& m2, respectively.
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 posted16 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelmoniem Abdallah Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310255
- Sponsor's protocol ID
- HPRD
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mueilo SH. Gastroduodenal lesions and Helicobacter pylori infection in hemodialysis patients. Saudi Med J. 2004 Aug;25(8):1010-4.
PubMed 15322589Atherton JC, Cao P, Peek RM Jr, Tummuru MK, Blaser MJ, Cover TL. Mosaicism in vacuolating cytotoxin alleles of Helicobacter pylori. Association of specific vacA types with cytotoxin production and peptic ulceration. J Biol Chem. 1995 Jul 28;270(30):17771-7. doi: 10.1074/jbc.270.30.17771.
PubMed 7629077Nasri H, Rafieian-Kopaei M. Significant association of serum H. pylori IgG antibody titer with kidney function in renal transplanted patients. J Renal Inj Prev. 2013 Mar 1;2(1):23-5. doi: 10.12861/jrip.2013.08. eCollection 2013.
PubMed 25340117Khedmat H, Ahmadzad-Asl M, Amini M, Lessan-Pezeshki M, Einollahi B, Pourfarziani V, Naseri MH, Davoudi F. Gastro-duodenal lesions and Helicobacter pylori infection in uremic patients and renal transplant recipients. Transplant Proc. 2007 May;39(4):1003-7. doi: 10.1016/j.transproceed.2007.03.034.
PubMed 17524875Miftahussurur M, Yamaoka Y. Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation. Biomed Res Int. 2016;2016:4819423. doi: 10.1155/2016/4819423. Epub 2016 Jan 19.
PubMed 26904678Wu CY, Kuo KN, Wu MS, Chen YJ, Wang CB, Lin JT. Early Helicobacter pylori eradication decreases risk of gastric cancer in patients with peptic ulcer disease. Gastroenterology. 2009 Nov;137(5):1641-8.e1-2. doi: 10.1053/j.gastro.2009.07.060. Epub 2009 Aug 5.
PubMed 19664631
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Infection in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT03310255
- Acronym / sponsor ID
- HPRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 16 Oct 2017 (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.
Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and because these drugs have many side effects that may not be differentiated from H. pylori infection Thus, in order to reduce the use of medications and subsequently to reduce the drug interactions ,proper detection and management of H pylori infection in those patients is preferred.
Detailed description
The prevalence of HP colonization is about 30% in the United States and other developed countries as opposed to more than 80% in most developing countries.
Essentially, all HP-colonized persons have gastric inflammation, but this condition in itself is asymptomatic.
Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal.
GI complications might require dose reduction or the discontinuation of some of the immunosuppressive medications, affecting graft survival.
Considering the strong body of evidence supporting causal effects of HP infections on the development of peptic ulcers and gastric malignancies, the argumented rate of gastrointestinal complaints may bebattributed to increased HP infection rate among this population.
Few studies have investigated the prevalence of HP infection; about 30% to 40% of renal transplant recipients shown HP colonization of the stomach There are conflicting data about the prevalence of H pylori infection in renal transplant recipients. Most of these studies used anti HP IgG to diagnose H. pylori infection that lack consistent sensitivity and specificity.
Nasri and his colleagues in 2013 concluded significant positive association of serum H. Pylori IgG antibody titer with renal function in renal transplant patient.
As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and because these drugs have many side effects that may not be differentiated from H. pylori infection Thus, in order to reduce the use of medications and subsequently to reduce the drug interactions ,proper detection and management of H pylori infection in those patients is preferred.
There are few studies have investigated the prevalence of HP infection; about 30% to 40% of renal transplant recipients shown HP colonization of the stomach. There are conflicting data about the prevalence of H pylori infection in renal transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post renal transplant patients, and patients proven to be h pylori positive will be subjected to further evaluation.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Patients in the first 1st. year after kidney transplantation.
- Patients diagnosed to have H.pylori infection by H.pylori fecal Ag will do endoscopy and biopsy.
Key exclusion criteria (3 listed)
- Patients who had previous upper endoscopy with evidence of gastritis or ulcers
- Age more than 65 years old
- Patients with any contraindications to upper endoscopy.
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 |
|---|---|---|
| H pylori Faecal AntigenAlso: Endoscopic Biopsy and culture, PCRAll patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy. | Diagnostic test | – |
Primary outcome
Prevalence of H pylori post Renal Transplant Patients
Time frame: 1 year
Percentage of H pylori positive patients in post renal transplant patients
Detection of CagA & VacA Genotypes by PCR:
Time frame: 1 year
Amplified DNA will be analyzed by agarose gel electrophoresis. The positive sample will produce bands at DNA fragment 138-bp for CagA, 259/286-bp for VacA S1/S2, 290-bp and 352-bp for m1 \& m2, respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Background: PubMed 15322589Al-Mueilo SH. Gastroduodenal lesions and Helicobacter pylori infection in hemodialysis patients. Saudi Med J. 2004 Aug;25(8):1010-4.
- Background: PubMed 7629077Atherton JC, Cao P, Peek RM Jr, Tummuru MK, Blaser MJ, Cover TL. Mosaicism in vacuolating cytotoxin alleles of Helicobacter pylori. Association of specific vacA types with cytotoxin production and peptic ulceration. J Biol Chem. 1995 Jul 28;270(30):17771-7. doi: 10.1074/jbc.270.30.17771.
- Background: PubMed 25340117Nasri H, Rafieian-Kopaei M. Significant association of serum H. pylori IgG antibody titer with kidney function in renal transplanted patients. J Renal Inj Prev. 2013 Mar 1;2(1):23-5. doi: 10.12861/jrip.2013.08. eCollection 2013.
- Background: PubMed 17524875Khedmat H, Ahmadzad-Asl M, Amini M, Lessan-Pezeshki M, Einollahi B, Pourfarziani V, Naseri MH, Davoudi F. Gastro-duodenal lesions and Helicobacter pylori infection in uremic patients and renal transplant recipients. Transplant Proc. 2007 May;39(4):1003-7. doi: 10.1016/j.transproceed.2007.03.034.
- Background: PubMed 26904678Miftahussurur M, Yamaoka Y. Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation. Biomed Res Int. 2016;2016:4819423. doi: 10.1155/2016/4819423. Epub 2016 Jan 19.
- Background: PubMed 19664631Wu CY, Kuo KN, Wu MS, Chen YJ, Wang CB, Lin JT. Early Helicobacter pylori eradication decreases risk of gastric cancer in patients with peptic ulcer disease. Gastroenterology. 2009 Nov;137(5):1641-8.e1-2. doi: 10.1053/j.gastro.2009.07.060. Epub 2009 Aug 5.
- 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 Helicobacter Pylori Infection and Renal Transplant Infection, 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 3 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 16 Oct 2017. 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 Mohamed A Mohamed, Msc (00201099428851, drmohamedabdallah1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of H pylori post Renal Transplant Patients (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03310255, which also lists 6 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 16 Oct 2017.