NCT03310255

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 11, 2017

Last Update Submit

October 11, 2017

Conditions

Helicobacter Pylori InfectionRenal Transplant Infection

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

H pylori Faecal AntigenDIAGNOSTIC_TEST

All patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy.

Also known as: Endoscopic Biopsy and culture, PCR

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

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

    PMID: 15322589BACKGROUND

  • 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.

    PMID: 7629077BACKGROUND

  • 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.

    PMID: 25340117BACKGROUND

  • 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.

    PMID: 17524875BACKGROUND

  • 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.

    PMID: 26904678BACKGROUND

  • 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.

    PMID: 19664631BACKGROUND

Central Study Contacts

Mohamed A Mohamed, Msc

CONTACT

00201099428851drmohamedabdallah1@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator at the department of Tropical medicine and gastroenterology

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2018

Study Completion

February 28, 2019

Last Updated

October 16, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share