Change of Transit or CirculationNCT01777204
Gastrointestinal Transit and Motility in Renal Transplant Recipients
An observational study of Change of Transit or Circulation and Effects of Immunosuppressant Therapy, run by Universidade Estadual de Ciências da Saúde de Alagoas at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Change of Transit or Circulation, Effects of Immunosuppressant Therapy
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jan 2013
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Renal transplant recipients from Alagoas, Brazil
Who may be able to join
- Healthy Volunteer or Renal Transplant Patients
- Signed informed consent obtained
- Fasted since midnight
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual de Ciências da Saúde de Alagoas
Maceió, Alagoas, 57010382
Maria do Carmo B Teixeira, Dr, +558233156722, maruchaborges@hotmail.com
Luciana A Cora, Dr, +558233156728, luciana.cora@uncisal.edu.br
About this study
Official title: Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique
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.
- Keywords
- Renal transplant, Gastrointestinal motility, Biomagnetism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of tacrolimus and cyclosporine on gastrointestinal transit
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change of Transit or CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ciências da Saúde de Alagoas
- Sponsor type
- University, hospital or other
- Collaborators
- UPECLIN HC FM Botucatu Unesp, University of Sao Paulo
- Responsible party
- Principal investigator, Maria do Carmo Borges, Universidade Estadual de Ciências da Saúde de Alagoas
- Investigators
- Maria do Carmo B Teixeira, Dr, Principal investigator, Universidade Estadual de Ciências da Saúde de Alagoas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777204
- Sponsor's protocol ID
- FAPEAL-20110714-TX
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique
- ClinicalTrials.gov ID
- NCT01777204
- Acronym / sponsor ID
- FAPEAL-20110714-TX
- Keywords
- Renal transplant, Gastrointestinal motility, Biomagnetism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Estadual de Ciências da Saúde de AlagoasUniversity, hospital or other
- Collaborators
- UPECLIN HC FM Botucatu Unesp, University of Sao Paulo
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Renal transplant recipients from Alagoas, Brazil
Key inclusion criteria (3 listed)
- Healthy Volunteer or Renal Transplant Patients
- Signed informed consent obtained
- Fasted since midnight
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influence of tacrolimus and cyclosporine on gastrointestinal transit
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria do Carmo B Teixeira, Dr principal investigator
Universidade Estadual de Ciências da Saúde de Alagoas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Change of Transit or Circulation and Effects of Immunosuppressant Therapy, run by Universidade Estadual de Ciências da Saúde de Alagoas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria do Carmo B Teixeira, PhD (+558233156722, maruchaborges@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of tacrolimus and cyclosporine on gastrointestinal transit (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.