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Gastrointestinal Transit and Motility in Renal Transplant Recipients

This study is currently recruiting participants.
Verified January 2013 by Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor:
Collaborators:
UPECLIN HC FM Botucatu Unesp
University of Sao Paulo
Information provided by (Responsible Party):
Maria do Carmo Borges, Universidade Estadual de Ciências da Saúde de Alagoas
ClinicalTrials.gov Identifier:
NCT01777204
First received: January 23, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Change of Transit or Circulation
Effects of Immunosuppressant Therapy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Estadual de Ciências da Saúde de Alagoas:

Primary Outcome Measures:
  • Influence of tacrolimus and cyclosporine on gastrointestinal transit [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Renal transplant recipients from Alagoas, Brazil

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777204

Contacts
Contact: Maria do Carmo B Teixeira, PhD +558233156722 maruchaborges@hotmail.com

Locations
Brazil
Universidade Estadual de Ciências da Saúde de Alagoas Recruiting
Maceio, Alagoas, Brazil, 57010382
Contact: Maria do Carmo B Teixeira, Dr     +558233156722     maruchaborges@hotmail.com    
Contact: Luciana A Cora, Dr     +558233156728     luciana.cora@uncisal.edu.br    
Principal Investigator: Maria do Carmo B Teixeira, Dr            
Sub-Investigator: Luciana A Cora, Dr            
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
  More Information

No publications provided

Responsible Party: Maria do Carmo Borges, Doctor, Universidade Estadual de Ciências da Saúde de Alagoas
ClinicalTrials.gov Identifier: NCT01777204     History of Changes
Other Study ID Numbers: FAPEAL-20110714-TX
Study First Received: January 23, 2013
Last Updated: January 23, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Estadual de Ciências da Saúde de Alagoas:
Renal transplant, Gastrointestinal motility, Biomagnetism

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013