Irritable Bowel SyndromeNCT02294760
Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.
A study testing Subsensory and OFF in people with Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Subsensory and OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.
The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
Read the detailed description
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Subsensory, OFF
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubsensoryDevice
Also called Device: External pacemaker, model 3625, Medtronic Inc.
The stimulation is set to 90% of the sensory threshold.
OFFDevice
Also called Device: External pacemaker, model 3625, Medtronic Inc.
The stimulation is turned OFF.
| Study group | Role | What they receive |
|---|---|---|
| Subsensory, OFF, subsensory | Active comparator | The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks. Receives: Device: Subsensory; Device: OFF |
| Subsensory, subsensory, OFF | Active comparator | The stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks. Receives: Device: Subsensory; Device: OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
The questionnaire is filled in every week of the 12 week study period
Measured: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
Secondary outcomes (1)
Irritable Bowel Syndrome - Impact Scale questionnaire
The questionnaire is filled in every week of the 12 week study period
Measured: Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janne Fassov, PhD, Principal investigator, Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294760
- Sponsor's protocol ID
- 44418
- Status last verified
- May 2018
- First submitted
- 10 Nov 2014
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT02294760
- Acronym / sponsor ID
- 44418
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Nov 2014 (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.
A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties.
The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subsensory, OFF, subsensory | Active comparator | Device: Subsensory, Device: OFFThe stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then turned OFF for the next 4 weeks and finally set subsensory for the last 4 weeks. |
| Subsensory, subsensory, OFF | Active comparator | Device: Subsensory, Device: OFFThe stimulator is set subsensory for the first 4 weeks (90% of sensory threshold), then set subsensory for another 4 weeks and finally turned OFF for the last 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SubsensoryAlso: Device: External pacemaker, model 3625, Medtronic Inc.The stimulation is set to 90% of the sensory threshold. | Device | Subsensory, OFF, subsensory, Subsensory, subsensory, OFF |
| OFFAlso: Device: External pacemaker, model 3625, Medtronic Inc.The stimulation is turned OFF. | Device | Subsensory, OFF, subsensory, Subsensory, subsensory, OFF |
Primary outcome
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version
Time frame: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study
The questionnaire is filled in every week of the 12 week study period
1 secondary outcome
Irritable Bowel Syndrome - Impact Scale questionnaire
Time frame: Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
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Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
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The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
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Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
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.
Janne Fassov, PhD principal investigator
Surgical Research Unit, Department of Surgery P, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subsensory and OFF in people with Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 17 May 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version (time frame: Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study). 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 17 May 2018.