Helicobacter Pylori Infection in Renal Transplant Patients

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection; Renal Transplant Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 86

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post renal transplant patients, and patients proven to be h pylori positive will be subjected to further evaluation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of H pylori post Renal Transplant Patients	Percentage of H pylori positive patients in post renal transplant patients	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.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: HPRD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No