Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
Launched by UNIVERSITY OF AARHUS · Nov 14, 2014
Trial Information
Current as of June 08, 2025
Completed
Keywords
ClinConnect Summary
Twenty two patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled by invitation in the study.
Having meet inclusion criteria, the patients are first set subsensory for 4 weeks and then randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 4+4-week period.
During the PNE test the effect of the stimulation is evaluated by specific IBS symptom and quality of life questionnaires (GSRS-IBS and IBS-IS) and bowel habit diaries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients who are psychologically stable and suitable for intervention and able to provide informed consent
- • Patients who are diagnosed with IBS according to the Rome III criteria and characterised with IBS-D or IBS-M.
- • Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.
- Exclusion Criteria:
- • Other bowel diseases including inflammatory bowel disease
- • Pregnant or breast feeding
- • Patients who are considered unable to follow the planned programme of the study, including mentally illness or physiological instability
- • Patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological diseases.
About University Of Aarhus
The University of Aarhus, a prestigious research institution located in Denmark, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages cutting-edge research and the development of novel therapeutic interventions. Committed to ethical standards and patient safety, the University of Aarhus aims to contribute to the global body of medical knowledge while enhancing healthcare outcomes through rigorous scientific inquiry and evidence-based practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aarhus, , Denmark
Patients applied
Trial Officials
Janne Fassov, PhD
Principal Investigator
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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