Helicobacter Pylori Infection in Renal Transplant Patients

October 11, 2017 updated by: Mohamed Abdelmoniem Abdallah Mohamed, Assiut University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of H pylori post Renal Transplant Patients
Time Frame: 1 year
Percentage of H pylori positive patients in post renal transplant patients
1 year
Detection of CagA & VacA Genotypes by PCR:
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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