Gastrointestinal Transit and Motility in Renal Transplant Recipients

Study Overview
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Brief Summary
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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.

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

Conditions
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Change of Transit or Circulation, Effects of Immunosuppressant Therapy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tacrolimus<br>Influence of tacrolimus on gastrointestinal transit and motility in renal transplant recipients. | |
| Cyclosporine<br>Influence of cyclosporine on gastrointestinal transit and motility in renal transplant recipients. | |
| Mycophenolate mofetil<br>Influence of mycophenolate mofetil on gastrointestinal transit and motility in renal transplant recipients. | |
| Mycophenolate sodium<br>Influence of mycophenolate sodium on gastrointestinal transit and motility in renal transplant recipients. | |
| Everolimus<br>Influence of everolimus on gastrointestinal transit and motility in renal transplant recipients. | |
| Sirolimus<br>influence of sirolimus on gastrointestinal transit and motility in renal transplant recipients. | |
| Without immunosuppression<br>Gastrointestinal transit and motility in healthy volunteers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of tacrolimus and cyclosporine on gastrointestinal transit |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Gastrointestinal motility, Biomagnetism