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Gastrointestinal Transit and Motility in Renal Transplant Recipients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Maria do Carmo Borges, Universidade Estadual de Ciências da Saúde de Alagoas.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777204
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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:


Further study details as provided by Maria do Carmo Borges, Universidade Estadual de Ciências da Saúde de Alagoas:

Primary Outcome Measures:
  • Influence of tacrolimus and cyclosporine on gastrointestinal transit [ Time Frame: one year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 23, 2013
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: January 2013

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

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


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