Gastrointestinal Transit and Motility in Renal Transplant Recipients

January 23, 2013 updated by: Maria do Carmo Borges, Universidade Estadual de Ciências da Saúde de Alagoas

Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique

Gastrointestinal (GI) complications after renal transplantation are commonly reported as side effects of immunosuppressive agents. Despite this, motility disorders have been scantily studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors designed for a wide range of applications. In clinical practice, their non-invasive and radiation free features provide an excellent approach for monitoring of GI transit as alternative to scintigraphy and breath tests. The aim of this study is to examine GI transit and motility of solids in stable renal transplant recipients to determine the potential influence of immunosuppressive therapy on gastrointestinal parameters.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

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

Study Locations

  • Brazil
    • Alagoas
      • Maceio, Alagoas, Brazil, 57010382
        • Recruiting
        • Universidade Estadual de Ciências da Saúde de Alagoas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria do Carmo B Teixeira, Dr
        • Sub-Investigator:
          • Luciana A Cora, Dr

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplant recipients from Alagoas, Brazil

Description

Inclusion Criteria:

  • Healthy Volunteer or Renal Transplant Patients
  • Signed informed consent obtained
  • Fasted since midnight

Exclusion Criteria:

  • Subject has known GI related symptoms complaints or GI diseases
  • Subject has cancer or other life threatening diseases or conditions
  • Subject is pregnant
  • Subject has undergone abdominal surgery
  • Drug abuse or alcoholism
  • Subject has cardiac pacemaker
  • Subject takes any medication affecting GI motility

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

Cohorts and Interventions

Group / Cohort
Tacrolimus
Influence of tacrolimus on gastrointestinal transit and motility in renal transplant recipients.
Cyclosporine
Influence of cyclosporine on gastrointestinal transit and motility in renal transplant recipients.
Mycophenolate mofetil
Influence of mycophenolate mofetil on gastrointestinal transit and motility in renal transplant recipients.
Mycophenolate sodium
Influence of mycophenolate sodium on gastrointestinal transit and motility in renal transplant recipients.
Everolimus
Influence of everolimus on gastrointestinal transit and motility in renal transplant recipients.
Sirolimus
influence of sirolimus on gastrointestinal transit and motility in renal transplant recipients.
Without immunosuppression
Gastrointestinal transit and motility in healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influence of tacrolimus and cyclosporine on gastrointestinal transit
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Universidade Estadual de Ciências da Saúde de Alagoas

Collaborators

University of Sao Paulo
UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Maria do Carmo B Teixeira, Dr, Universidade Estadual de Ciências da Saúde de Alagoas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAPEAL-20110714-TX

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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