Gastrointestinal Transit and Motility in Renal Transplant Recipients

NCT01777204 | Unknown DMC

• 1 other identifier: FAPEAL-20110714-TX
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Change of Transit or Circulation; Effects of Immunosuppressant Therapy

Keywords

Renal transplant, Gastrointestinal motility, Biomagnetism

Outcome Measures

Primary Outcomes (1)

• Influence of tacrolimus and cyclosporine on gastrointestinal transit

  one year

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Renal transplant recipients from Alagoas, Brazil

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Universidade Estadual de Ciências da Saúde de Alagoas

Maceió, Alagoas, 57010382, Brazil

RECRUITING

Study Officials

• Maria do Carmo B Teixeira, Dr

  Universidade Estadual de Ciências da Saúde de Alagoas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria do Carmo B Teixeira, PhD

CONTACT

+558233156722; maruchaborges@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

BR (1)