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Gastrointestinal Transit and Motility in Renal Transplant Recipients

Sponsor
Universidade Estadual de Ciências da Saúde de Alagoas (Other)
Overall Status
Unknown status
CT.gov ID
NCT01777204
Collaborator
UPECLIN HC FM Botucatu Unesp (Other), University of Sao Paulo (Other)
20
Enrollment
1
Location
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Jan 1, 2013
    Anticipated Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Influence of tacrolimus and cyclosporine on gastrointestinal transit [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade Estadual de Ciências da Saúde de Alagoas Maceio Alagoas Brazil 57010382

    Sponsors and Collaborators

    • Universidade Estadual de Ciências da Saúde de Alagoas
    • UPECLIN HC FM Botucatu Unesp
    • University of Sao Paulo

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria do Carmo Borges, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas
    ClinicalTrials.gov Identifier:
    NCT01777204
    Other Study ID Numbers:
    • FAPEAL-20110714-TX
    First Posted:
    Jan 28, 2013
    Last Update Posted:
    Jan 28, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Maria do Carmo Borges, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas
    Renal transplant, Gastrointestinal motility, Biomagnetism

    Study Results

    No Results Posted as of Jan 28, 2013