Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT01777204
Status:
UNKNOWN
Last Update Posted:
2013-01-28
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Transit and Motility in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of tacrolimus and cyclosporine on gastrointestinal transit', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal transplant, Gastrointestinal motility, Biomagnetism'], 'conditions': ['Change of Transit or Circulation', 'Effects of Immunosuppressant Therapy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal transplant recipients from Alagoas, Brazil', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteer or Renal Transplant Patients\n* Signed informed consent obtained\n* Fasted since midnight\n\nExclusion Criteria:\n\n* Subject has known GI related symptoms complaints or GI diseases\n* Subject has cancer or other life threatening diseases or conditions\n* Subject is pregnant\n* Subject has undergone abdominal surgery\n* Drug abuse or alcoholism\n* Subject has cardiac pacemaker\n* Subject takes any medication affecting GI motility'}, 'identificationModule': {'nctId': 'NCT01777204', 'briefTitle': 'Gastrointestinal Transit and Motility in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual de Ciências da Saúde de Alagoas'}, 'officialTitle': 'Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique', 'orgStudyIdInfo': {'id': 'FAPEAL-20110714-TX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tacrolimus', 'description': 'Influence of tacrolimus on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Cyclosporine', 'description': 'Influence of cyclosporine on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Mycophenolate mofetil', 'description': 'Influence of mycophenolate mofetil on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Mycophenolate sodium', 'description': 'Influence of mycophenolate sodium on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Everolimus', 'description': 'Influence of everolimus on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Sirolimus', 'description': 'influence of sirolimus on gastrointestinal transit and motility in renal transplant recipients.'}, {'label': 'Without immunosuppression', 'description': 'Gastrointestinal transit and motility in healthy volunteers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57010382', 'city': 'Maceió', 'state': 'Alagoas', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maria do Carmo B Teixeira, Dr', 'role': 'CONTACT', 'email': 'maruchaborges@hotmail.com', 'phone': '+558233156722'}, {'name': 'Luciana A Cora, Dr', 'role': 'CONTACT', 'email': 'luciana.cora@uncisal.edu.br', 'phone': '+558233156728'}, {'name': 'Maria do Carmo B Teixeira, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luciana A Cora, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidade Estadual de Ciências da Saúde de Alagoas', 'geoPoint': {'lat': -9.66583, 'lon': -35.73528}}], 'centralContacts': [{'name': 'Maria do Carmo B Teixeira, PhD', 'role': 'CONTACT', 'email': 'maruchaborges@hotmail.com', 'phone': '+558233156722'}], 'overallOfficials': [{'name': 'Maria do Carmo B Teixeira, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual de Ciências da Saúde de Alagoas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual de Ciências da Saúde de Alagoas', 'class': 'OTHER'}, 'collaborators': [{'name': 'UPECLIN HC FM Botucatu Unesp', 'class': 'OTHER'}, {'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Maria do Carmo Borges', 'investigatorAffiliation': 'Universidade Estadual de Ciências da Saúde de Alagoas'}}}}