Helicobacter Pylori Infection in Renal Transplant Patients

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03310255
Collaborator
(none)
86
15.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: H pylori Faecal Antigen

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

Study Type:
Observational
Anticipated Enrollment :
86 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Helicobacter Pylori Infection in Renal Transplant Patients
Anticipated Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Feb 28, 2019

Outcome Measures

Primary Outcome Measures

  1. Prevalence of H pylori post Renal Transplant Patients [1 year]

    Percentage of H pylori positive patients in post renal transplant patients

  2. Detection of CagA & VacA Genotypes by PCR: [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdelmoniem Abdallah Mohamed, Principal Investigator at the department of Tropical medicine and gastroenterology, Assiut University
ClinicalTrials.gov Identifier:
NCT03310255
Other Study ID Numbers:
  • HPRD
First Posted:
Oct 16, 2017
Last Update Posted:
Oct 16, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2017