Helicobacter Pylori Infection in Renal Transplant Patients
NCT ID: NCT03310255
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
86 participants
OBSERVATIONAL
2017-11-01
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
H pylori Faecal Antigen
All patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Age more than 65 years old
* Patients with any contraindications to upper endoscopy.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Abdelmoniem Abdallah Mohamed
Principal Investigator at the department of Tropical medicine and gastroenterology
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Al-Mueilo SH. Gastroduodenal lesions and Helicobacter pylori infection in hemodialysis patients. Saudi Med J. 2004 Aug;25(8):1010-4.
Atherton 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.
Nasri 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.
Khedmat 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.
Miftahussurur 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.
Wu 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HPRD
Identifier Type: -
Identifier Source: org_study_id