Irritable Bowel SyndromeNCT01950715
Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome
A study testing sacral nerve stimulation in people with Irritable Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. 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?
- sacral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Mar 2018
- 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 aged over 18
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria
- Minimum average of 40 points in the symptom questionnaire evaluated at baseline
Who cannot join
- Overt 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 disease
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: Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.
Read the detailed description
Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.
Having meet inclusion criteria, the patients will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.
During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.
The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.
Here patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a stimulation test period of a total of 6 weeks (a permanent electrode is used).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- sacral nerve stimulation
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Gastro-colic response, Multimodal Stimulation
- 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.
sacral nerve stimulationDevice
Also called External pacemaker, model 3625, Medtronic Inc.
Sacral nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| sacral nerve stimulation | Other | A single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation Receives: Device: sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation
Measured: Change from baseline in cross sectional area at 6 weeks of stimulation
Secondary outcomes (4)
Wall stiffness
Patients will be examined with Multimodal Stimulation using impedance planimetry calculating the wall stiffness before and after a standardised meal at baseline and at 6 weeks of stimulation
Measured: Change from baseline in wall stiffness at 6 weeks of stimulation
Compliance
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the compliance before and after a standardised meal at baseline and at 6 weeks of stimulation
Measured: Change from baseline in compliance at 6 weeks of stimulation
Cold
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cold tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation
Measured: Change from baseline in cold tolerance at 6 weeks of stimulation
Heat
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the heat tolerance before and after a standardised meal at baseline and at 6 weeks of stimulation
Measured: Change from baseline in heat tolerance at 6 weeks of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2018
- Study completionMar 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- 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
- NCT01950715
- Sponsor's protocol ID
- 201302, JLF
- Status last verified
- May 2018
- First submitted
- 12 Sep 2013
- Last updated
- 21 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 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gastro-colic Response in IBS Patients Treated With Sacral Nerve Stimulation
- ClinicalTrials.gov ID
- NCT01950715
- Acronym / sponsor ID
- 201302, JLF
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Sacral Nerve Stimulation, Gastro-colic response, Multimodal Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Sep 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.
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown changes in both colonic motility and rectal sensibility. The investigators have previously shown IBS patients to benefit from sacral nerves stimulation. With the present study, the investigators aim to evaluate if sacral nerve stimulation alters the gastro-colic response in IBS patients.
Detailed description
Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled in the study.
Having meet inclusion criteria, the patients will be examined with Multimodal Stimulation at baseline and at six weeks in the sacral nerve stimulation test period.
During the Multimodal Stimulation the patients will have impedance planimetry conducted before and after a standardised meal to evaluate on their gastro-colic response without and during sacral nerve stimulation.
The patients enrolled in the study will in the same time period participate in another study evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.
Here patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a stimulation test period of a total of 6 weeks (a permanent electrode is used).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacral nerve stimulation | Other | Device: sacral nerve stimulationA single armed study to evaluate the on the gastro-colic response in IBS patients treated with sacral nerve stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged over 18
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent.
- Patients who are diagnosed with IBS-D or IBS-M according to the Rome III criteria
- Minimum average of 40 points in the symptom questionnaire evaluated at baseline
Key exclusion criteria (4 listed)
- Overt 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 disease
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 |
|---|---|---|
| sacral nerve stimulationAlso: External pacemaker, model 3625, Medtronic Inc.Sacral nerve stimulation | Device | sacral nerve stimulation |
Primary outcome
Cross sectional area
Time frame: Change from baseline in cross sectional area at 6 weeks of stimulation
Patients will be examined with Multimodal Stimulation using impedance planimetry measuring the cross sectional area before and after a standardised meal at baseline and at 6 weeks of stimulation
4 secondary outcomes
Wall stiffness
Time frame: Change from baseline in wall stiffness at 6 weeks of stimulation
Compliance
Time frame: Change from baseline in compliance at 6 weeks of stimulation
Cold
Time frame: Change from baseline in cold tolerance at 6 weeks of stimulation
Heat
Time frame: Change from baseline in heat tolerance at 6 weeks of stimulation
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 21 May 2018.
- Individual participant dataSharing planned: Undecided
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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 sacral nerve stimulation 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 4 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 21 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?
Cross sectional area (time frame: Change from baseline in cross sectional area at 6 weeks of stimulation). 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 21 May 2018.