Gastrointestinal Transit and Motility in Renal Transplant Recipients

Effects of Immunosuppressant Therapy Clinical Trial

Official title:

Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01777204
• Other study ID #: FAPEAL-20110714-TX
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 23, 2013
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Universidade Estadual de Ciências da Saúde de Alagoas
• Contact: Maria do Carmo B Teixeira, PhD
• Phone: +558233156722
• Email: maruchaborges[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Change of Transit or Circulation
• Effects of Immunosuppressant Therapy

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Ciências da Saúde de Alagoas	Maceio	Alagoas

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Estadual de Ciências da Saúde de Alagoas	University of Sao Paulo, UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of tacrolimus and cyclosporine on gastrointestinal transit		one year	No