Helicobacter Pylori Infection in Renal Transplant Patients

Helicobacter Pylori Infection Clinical Trial

Official title:

Helicobacter Pylori Infection in Renal Transplant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03310255
• Other study ID #: HPRD
• Status: Not yet recruiting
• Phase: N/A
• First received: October 11, 2017
• Last updated: October 11, 2017
• Start date: November 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: Mohamed A Mohamed, Msc
• Phone: 00201099428851
• Email: drmohamedabdallah1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: February 28, 2019
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Renal Transplant Infection

Intervention

Diagnostic Test:
• H pylori Faecal Antigen
All patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Al-Mueilo SH. Gastroduodenal lesions and Helicobacter pylori infection in hemodialysis patients. Saudi Med J. 2004 Aug;25(8):1010-4. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of H pylori post Renal Transplant Patients	Percentage of H pylori positive patients in post renal transplant patients	1 year
Primary	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