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Gastrointestinal Transit and Motility in Renal Transplant Recipients

U

Universidade Estadual de Ciências da Saúde de Alagoas

Status

Unknown

Conditions

Effects of Immunosuppressant Therapy
Change of Transit or Circulation

Study type

Observational

Funder types

Other

Identifiers

NCT01777204
FAPEAL-20110714-TX

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 7 patient groups

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

Trial contacts and locations

1

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Central trial contact

Maria do Carmo B Teixeira, PhD

Data sourced from clinicaltrials.gov

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