Irritable Bowel Syndrome (IBS)NCT06769516
Exercise and Vagus Nerve Stimulation in IBS
A study testing Auricular Vagus Nerve Stimulation (aVNS), Aerobic Exercise Therapy and Low FODMAP Diet Intervention in people with Irritable Bowel Syndrome (IBS), run by Bahçeşehir University at 1 site in United Kingdom.
Trial summary
The aim of the study was to consider the possible role of exercise and vagus nerve on bowel functionality in chronic IBS and to demonstrate that exercise and transcutaneous auricular stimulation of the vagus nerve can reduce these symptoms in the treatment of these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Auricular Vagus Nerve Stimulation (aVNS), Aerobic Exercise Therapy and Low FODMAP Diet Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to 1 Jan 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS for more than 1 year
- Patients with persistent IBS symptoms despite standard conventional treatments
- To be between the ages of 18-65
- Being suitable for exercise
- To be willing and voluntary to participate in the thesis study
Who cannot join
- People with inflammatory diseases
- Uncooperative patients
- Participants do not want to continue working
- Failure to sign the informed consent form
- History of additional chronic diseases that may prevent physical activity
- Pregnancy
- Long-term use of analgesics for more than 3 months
- Acute infection in the auricular region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise and Vagus Nerve Stimulation on the Intestines in Irritable Bowel Syndrome
The aim of the study was to consider the possible role of exercise and vagus nerve on bowel functionality in chronic IBS and to demonstrate that exercise and transcutaneous auricular stimulation of the vagus nerve can reduce these symptoms in the treatment of these patients.
Read the detailed description
The study will consist of people living in the Manchester region who are diagnosed with chronic IBS and who want to volunteer for the study. Informed consent forms will be signed by all volunteers and these forms will be kept in the file. The number of people who will participate in the study was determined using G Power analysis and the number of samples was calculated as 1st group 30 people, 2nd group 30 people and 3rd group 30 people, totalling 90 people. Individuals with IBS were randomly divided into three groups and diet only [low FODMAP diet (fermentable oligo-di-mono-saccharides and polyols)], diet + aerobic exercise and diet + vagustim will be applied.
- st group: The specified diet will be applied for 4 weeks.
- nd group: Aerobic exercise will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.
- rd group: Vagustim will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.
The low FODMAP (fermentable oligo-di-mono-saccharides and polyols) diet to be applied for the nutrition of the participants will be given to each individual as training before the study. In our study, vagus nerve stimulation will be applied through the ear. Aerobic exercises will be demonstrated one-to-one and the application of the patients will be monitored and the vagustim device will be applied to the groups in the clinic. In the intervention group, the vagustim device consisting of earphones placed in the outer ear, which can be selected as S, M, L according to the size of the individual's ear, and a tens device connected to the earphones will be used. The earphones will be placed to hit the tragus and concha and the device will be applied for 30 minutes with a pulse duration of less than 500 microseconds, frequency of 10 Hz and modulated TENS mode, and the current intensity will be adjusted according to the sensory threshold of the individual.
The group given aerobic exercise will be given walking exercise for 4 weeks, 3 days a week, for at least 30 minutes and at a moderate intensity not exceeding 50-70% of the maximal heart rate (if the pulse cannot be counted during sports, the criterion is that the person can talk comfortably). In our study, the decision of aerobic exercise to be given to a group was made by reviewing the literature.
Heart rate variability of the participants before and after the study will be evaluated with Polar H10 HR heart rate sensor. The bowel sounds of the participants before and after the study will be measured using a Littmann 4100 model electronic stethoscope. The first and last measurements will be measured according to the same standards and these standards are as follows: The measurements will be performed 2 hours after the last meal of the person who has not smoked for the last 2 hours before the measurements and has not consumed alcohol (permitted amount) in the last 12 hours. At the same time, 'Sociodemographic Form', 'SF-36', 'International Physical Activity Questionnaire Short Last 7 Days Self-Administered Form', 'Bristol Stool Form Scale (BSFS)' and 'Irritable Bowel Syndrome- Symptom Severity Scale (IBS-SSS)' scales will be applied to the individuals.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Auricular Vagus Nerve Stimulation (aVNS), Aerobic Exercise Therapy, Low FODMAP Diet Intervention
- Keywords
- Irritable Bowel Syndrome, Vagus Nerve Stimulation, Exercise Therapy, Diet, Low FODMAP, Heart Rate Variability
- 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.
Auricular Vagus Nerve Stimulation (aVNS)Device
Also called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), VagusStim Device Therapy, Electrical Stimulation of Auricular Vagus Nerve, TENS-Based Auricular Stimulation
This intervention involves transcutaneous auricular vagus nerve stimulation (taVNS) using the VagusStim device. The device consists of earphones tailored to fit the individual's ear size (S, M, L) and is connected to a TENS unit. The stimulation is applied to the tragus and concha of the ear for 30 minutes, three times a week, over a 4-week period. The device operates with a pulse duration of less than 500 microseconds, a frequency of 10 Hz, and in a modulated TENS mode. The current intensity is individually adjusted to the participant's sensory threshold. This method targets the vagus nerve to potentially regulate autonomic activity and improve symptoms of Irritable Bowel Syndrome (IBS).
The study combines this intervention with a low FODMAP diet for all participants, distinguishing it from studies focused solely on vagus nerve stimulation or dietary changes.
Aerobic Exercise TherapyBehavioural
Also called Moderate-Intensity Walking Program, Aerobic Physical Activity Intervention, Walking Therapy for IBS
This intervention involves a structured aerobic exercise program designed to improve physical activity levels and modulate symptoms of Irritable Bowel Syndrome (IBS). Participants engage in walking exercises at a moderate intensity, maintaining 50-70% of their maximum heart rate, ensuring the ability to converse comfortably during the activity. The exercise sessions last for at least 30 minutes, three days a week, on alternate days, over a 4-week period.
Participants are individually trained and monitored to ensure proper technique and adherence to the exercise protocol. The intervention is combined with a low FODMAP diet, providing a multimodal approach to IBS symptom management. This distinguishes it from other interventions by emphasizing physical activity's role in enhancing gastrointestinal and overall health.
Low FODMAP Diet InterventionBehavioural
Also called Low FODMAP Nutritional Therapy, FODMAP-Restricted Diet, IBS Symptom-Targeted Diet
This intervention involves the implementation of a low FODMAP (fermentable oligo-, di-, mono-saccharides, and polyols) diet to manage symptoms of Irritable Bowel Syndrome (IBS). Participants receive individualized training on the diet before the study begins. The diet eliminates high FODMAP foods known to exacerbate IBS symptoms, such as certain fruits, vegetables, dairy products, and sweeteners, for a duration of 4 weeks.
Participants follow the prescribed dietary protocol under guidance, ensuring adherence and addressing specific nutritional needs. This intervention aims to reduce gastrointestinal distress by limiting fermentable carbohydrates, distinguishing it from other IBS management strategies that do not focus on dietary modifications.
| Study group | Role | What they receive |
|---|---|---|
| 1st Group: Low FODMAP Diet Only | Experimental | Participants in this group will follow a Low FODMAP diet for a period of 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols-types of carbohydrates that are known to cause digestive issues in individuals with IBS. Prior to the start of the study, each participant will receive training on the diet and will be instructed on which foods to avoid and which to include. The goal is to assess the effect of the diet alone on the participants' IBS symptoms, including their bowel function and overall digestive health. Receives: Behavioral: Low FODMAP Diet Intervention |
| 2nd Group: Low FODMAP Diet + Aerobic Exercise | Experimental | Participants in this group will follow a Low FODMAP diet combined with an aerobic exercise regimen for a duration of 4 weeks. The Low FODMAP diet aims to reduce the intake of fermentable carbohydrates that may trigger IBS symptoms. Along with the dietary intervention, participants will engage in moderate-intensity aerobic exercise, such as walking, three times per week for at least 30 minutes per session. The intensity will be set to 50-70% of their maximum heart rate, and participants will be encouraged to exercise at a level where they can comfortably talk while moving. The goal is to evaluate the combined effect of dietary modification and regular exercise on IBS symptoms, bowel function, and overall health. Receives: Behavioral: Aerobic Exercise Therapy; Behavioral: Low FODMAP Diet Intervention |
| 3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim) | Experimental | Participants in this group will follow a Low FODMAP diet combined with vagus nerve stimulation (Vagustim) for 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable carbohydrates, which are known to trigger IBS symptoms. In addition to the dietary intervention, participants will receive vagus nerve stimulation via an ear-based device (Vagustim), applied three times a week. This device will be used for 30-minute sessions, with settings tailored to each participant's sensory threshold. Vagus nerve stimulation is believed to positively influence the autonomic nervous system and may improve IBS symptoms by reducing inflammation and modulating gut-brain signaling. The combined effect of diet and vagus nerve stimulation will be assessed to evaluate their impact on IBS symptoms, bowel function, and overall wellbeing. Receives: Device: Auricular Vagus Nerve Stimulation (aVNS); Behavioral: Low FODMAP Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS Symptom Severity as Measured by IBS-SSS
The primary outcome measure of this study is the change in IBS symptoms, assessed using the IBS-Symptom Severity Scale (IBS-SSS). This scale evaluates the severity of key symptoms of irritable bowel syndrome, including abdominal pain, bloating, and the frequency and severity of bowel movements. Participants will complete the IBS-SSS questionnaire before and after the 4-week intervention period, which includes the low FODMAP diet, aerobic exercise, or vagus nerve stimulation (Vagustim). The change in the IBS-SSS score will be used to assess the impact of the interventions on symptom severity and provide insight into the efficacy of each treatment approach.
Measured: Pre- and post-intervention (after 4 weeks of Low FODMAP diet only, Low FODMAP diet + aerobic exercise, or Low FODMAP diet + vagus nerve stimulation). IBS-Symptom Severity Scale (IBS-SSS) will be administered at baseline and after 4 weeks.
Secondary outcomes (4)
Heart Rate Variability (HRV)
Heart rate variability (HRV) will be measured using the Polar H10 HR heart rate sensor. HRV is a key indicator of autonomic nervous system function and may be influenced by vagus nerve stimulation or aerobic exercise.
Measured: Pre- and post-intervention (after 4 weeks).
Bowel Sounds
Bowel sounds will be measured using the Littmann 4100 model electronic stethoscope. Bowel sounds provide information on digestive function and can reflect changes due to diet or interventions.
Measured: Pre- and post-intervention (after 4 weeks).
Quality of Life (SF-36)
Quality of life changes will be assessed using the SF-36 questionnaire. This measure evaluates the impact of IBS and its interventions on participants' general health and well-being.
Measured: Pre- and post-intervention (after 4 weeks).
Physical Activity Levels (IPAQ)
Physical activity levels will be measured using the International Physical Activity Questionnaire (IPAQ) Short Last 7 Days Self-Administered Form. This assesses participants' activity levels and potential changes due to interventions.
Measured: Pre- and post-intervention (after 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Parallel groups
- Model description
- The study utilizes a parallel assignment model, where participants are randomly assigned to one of three independent groups: Group 1: Low FODMAP diet only. Group 2: Low FODMAP diet combined with aerobic exercise. Group 3: Low FODMAP diet combined with vagus nerve stimulation using the VagusStim device. Each group undergoes its assigned intervention for a duration of 4 weeks. There is no crossover between groups, and all participants are evaluated separately based on their respective intervention outcomes.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Dere, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769516
- Sponsor's protocol ID
- BAU-FTR-HD-01
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and Vagus Nerve Stimulation on the Intestines in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06769516
- Acronym / sponsor ID
- BAU-FTR-HD-01
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable Bowel Syndrome, Vagus Nerve Stimulation, Exercise Therapy, Diet, Low FODMAP, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 10 Jan 2025 (actual)
- 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.
The aim of the study was to consider the possible role of exercise and vagus nerve on bowel functionality in chronic IBS and to demonstrate that exercise and transcutaneous auricular stimulation of the vagus nerve can reduce these symptoms in the treatment of these patients.
Detailed description
The study will consist of people living in the Manchester region who are diagnosed with chronic IBS and who want to volunteer for the study. Informed consent forms will be signed by all volunteers and these forms will be kept in the file. The number of people who will participate in the study was determined using G Power analysis and the number of samples was calculated as 1st group 30 people, 2nd group 30 people and 3rd group 30 people, totalling 90 people. Individuals with IBS were randomly divided into three groups and diet only [low FODMAP diet (fermentable oligo-di-mono-saccharides and polyols)], diet + aerobic exercise and diet + vagustim will be applied.
- st group: The specified diet will be applied for 4 weeks.
- nd group: Aerobic exercise will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.
- rd group: Vagustim will be applied 3 days a week (every other day) with the diet programme determined for 4 weeks.
The low FODMAP (fermentable oligo-di-mono-saccharides and polyols) diet to be applied for the nutrition of the participants will be given to each individual as training before the study. In our study, vagus nerve stimulation will be applied through the ear. Aerobic exercises will be demonstrated one-to-one and the application of the patients will be monitored and the vagustim device will be applied to the groups in the clinic. In the intervention group, the vagustim device consisting of earphones placed in the outer ear, which can be selected as S, M, L according to the size of the individual's ear, and a tens device connected to the earphones will be used. The earphones will be placed to hit the tragus and concha and the device will be applied for 30 minutes with a pulse duration of less than 500 microseconds, frequency of 10 Hz and modulated TENS mode, and the current intensity will be adjusted according to the sensory threshold of the individual.
The group given aerobic exercise will be given walking exercise for 4 weeks, 3 days a week, for at least 30 minutes and at a moderate intensity not exceeding 50-70% of the maximal heart rate (if the pulse cannot be counted during sports, the criterion is that the person can talk comfortably). In our study, the decision of aerobic exercise to be given to a group was made by reviewing the literature.
Heart rate variability of the participants before and after the study will be evaluated with Polar H10 HR heart rate sensor. The bowel sounds of the participants before and after the study will be measured using a Littmann 4100 model electronic stethoscope. The first and last measurements will be measured according to the same standards and these standards are as follows: The measurements will be performed 2 hours after the last meal of the person who has not smoked for the last 2 hours before the measurements and has not consumed alcohol (permitted amount) in the last 12 hours. At the same time, 'Sociodemographic Form', 'SF-36', 'International Physical Activity Questionnaire Short Last 7 Days Self-Administered Form', 'Bristol Stool Form Scale (BSFS)' and 'Irritable Bowel Syndrome- Symptom Severity Scale (IBS-SSS)' scales will be applied to the individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study utilizes a parallel assignment model, where participants are randomly assigned to one of three independent groups: Group 1: Low FODMAP diet only. Group 2: Low FODMAP diet combined with aerobic exercise. Group 3: Low FODMAP diet combined with vagus nerve stimulation using the VagusStim device. Each group undergoes its assigned intervention for a duration of 4 weeks. There is no crossover between groups, and all participants are evaluated separately based on their respective intervention outcomes.
| Arm | Type | Receives |
|---|---|---|
| 1st Group: Low FODMAP Diet Only | Experimental | Behavioral: Low FODMAP Diet InterventionParticipants in this group will follow a Low FODMAP diet for a period of 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols-types of carbohydrates that are known to cause digestive issues in individuals with IBS. Prior to the start of the study, each participant will receive training on the diet and will be instructed on which foods to avoid and which to include. The goal is to assess the effect of the diet alone on the participants' IBS symptoms, including their bowel function and overall digestive health. |
| 2nd Group: Low FODMAP Diet + Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise Therapy, Behavioral: Low FODMAP Diet InterventionParticipants in this group will follow a Low FODMAP diet combined with an aerobic exercise regimen for a duration of 4 weeks. The Low FODMAP diet aims to reduce the intake of fermentable carbohydrates that may trigger IBS symptoms. Along with the dietary intervention, participants will engage in moderate-intensity aerobic exercise, such as walking, three times per week for at least 30 minutes per session. The intensity will be set to 50-70% of their maximum heart rate, and participants will be encouraged to exercise at a level where they can comfortably talk while moving. The goal is to evaluate the combined effect of dietary modification and regular exercise on IBS symptoms, bowel function, and overall health. |
| 3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim) | Experimental | Device: Auricular Vagus Nerve Stimulation (aVNS), Behavioral: Low FODMAP Diet InterventionParticipants in this group will follow a Low FODMAP diet combined with vagus nerve stimulation (Vagustim) for 4 weeks. The Low FODMAP diet is designed to reduce the intake of fermentable carbohydrates, which are known to trigger IBS symptoms. In addition to the dietary intervention, participants will receive vagus nerve stimulation via an ear-based device (Vagustim), applied three times a week. This device will be used for 30-minute sessions, with settings tailored to each participant's sensory threshold. Vagus nerve stimulation is believed to positively influence the autonomic nervous system and may improve IBS symptoms by reducing inflammation and modulating gut-brain signaling. The combined effect of diet and vagus nerve stimulation will be assessed to evaluate their impact on IBS symptoms, bowel function, and overall wellbeing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IBS for more than 1 year
- Patients with persistent IBS symptoms despite standard conventional treatments
- To be between the ages of 18-65
- Being suitable for exercise
- To be willing and voluntary to participate in the thesis study
Key exclusion criteria (8 listed)
- People with inflammatory diseases
- Uncooperative patients
- Participants do not want to continue working
- Failure to sign the informed consent form
- History of additional chronic diseases that may prevent physical activity
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 |
|---|---|---|
| Auricular Vagus Nerve Stimulation (aVNS)Also: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), VagusStim Device Therapy, Electrical Stimulation of Auricular Vagus Nerve, TENS-Based Auricular StimulationThis intervention involves transcutaneous auricular vagus nerve stimulation (taVNS) using the VagusStim device. The device consists of earphones tailored to fit the individual's ear size (S, M, L) and is connected to a TENS unit. The stimulation is applied to the tragus and concha of the ear for 30 minutes, three times a week, over a 4-week period. The device operates with a pulse duration of less than 500 microseconds, a frequency of 10 Hz, and in a modulated TENS mode. The current intensity is individually adjusted to the participant's sensory threshold. This method targets the vagus nerve to potentially regulate autonomic activity and improve symptoms of Irritable Bowel Syndrome (IBS). The study combines this intervention with a low FODMAP diet for all participants, distinguishing it from studies focused solely on vagus nerve stimulation or dietary changes. | Device | 3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim) |
| Aerobic Exercise TherapyAlso: Moderate-Intensity Walking Program, Aerobic Physical Activity Intervention, Walking Therapy for IBSThis intervention involves a structured aerobic exercise program designed to improve physical activity levels and modulate symptoms of Irritable Bowel Syndrome (IBS). Participants engage in walking exercises at a moderate intensity, maintaining 50-70% of their maximum heart rate, ensuring the ability to converse comfortably during the activity. The exercise sessions last for at least 30 minutes, three days a week, on alternate days, over a 4-week period. Participants are individually trained and monitored to ensure proper technique and adherence to the exercise protocol. The intervention is combined with a low FODMAP diet, providing a multimodal approach to IBS symptom management. This distinguishes it from other interventions by emphasizing physical activity's role in enhancing gastrointestinal and overall health. | Behavioural | 2nd Group: Low FODMAP Diet + Aerobic Exercise |
| Low FODMAP Diet InterventionAlso: Low FODMAP Nutritional Therapy, FODMAP-Restricted Diet, IBS Symptom-Targeted DietThis intervention involves the implementation of a low FODMAP (fermentable oligo-, di-, mono-saccharides, and polyols) diet to manage symptoms of Irritable Bowel Syndrome (IBS). Participants receive individualized training on the diet before the study begins. The diet eliminates high FODMAP foods known to exacerbate IBS symptoms, such as certain fruits, vegetables, dairy products, and sweeteners, for a duration of 4 weeks. Participants follow the prescribed dietary protocol under guidance, ensuring adherence and addressing specific nutritional needs. This intervention aims to reduce gastrointestinal distress by limiting fermentable carbohydrates, distinguishing it from other IBS management strategies that do not focus on dietary modifications. | Behavioural | 1st Group: Low FODMAP Diet Only, 2nd Group: Low FODMAP Diet + Aerobic Exercise, 3rd Group: Low FODMAP Diet + Vagus Nerve Stimulation (Vagustim) |
Primary outcome
Change in IBS Symptom Severity as Measured by IBS-SSS
Time frame: Pre- and post-intervention (after 4 weeks of Low FODMAP diet only, Low FODMAP diet + aerobic exercise, or Low FODMAP diet + vagus nerve stimulation). IBS-Symptom Severity Scale (IBS-SSS) will be administered at baseline and after 4 weeks.
The primary outcome measure of this study is the change in IBS symptoms, assessed using the IBS-Symptom Severity Scale (IBS-SSS). This scale evaluates the severity of key symptoms of irritable bowel syndrome, including abdominal pain, bloating, and the frequency and severity of bowel movements. Participants will complete the IBS-SSS questionnaire before and after the 4-week intervention period, which includes the low FODMAP diet, aerobic exercise, or vagus nerve stimulation (Vagustim). The change in the IBS-SSS score will be used to assess the impact of the interventions on symptom severity and provide insight into the efficacy of each treatment approach.
4 secondary outcomes
Heart Rate Variability (HRV)
Time frame: Pre- and post-intervention (after 4 weeks).
Bowel Sounds
Time frame: Pre- and post-intervention (after 4 weeks).
Quality of Life (SF-36)
Time frame: Pre- and post-intervention (after 4 weeks).
Physical Activity Levels (IPAQ)
Time frame: Pre- and post-intervention (after 4 weeks).
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 10 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Vagus Nerve Stimulation (aVNS), Aerobic Exercise Therapy and Low FODMAP Diet Intervention in people with Irritable Bowel Syndrome (IBS), run by Bahçeşehir University at 1 site in United Kingdom.
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 5 inclusion and 8 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 10 Jan 2025. 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 United Kingdom. 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?
Change in IBS Symptom Severity as Measured by IBS-SSS (time frame: Pre- and post-intervention (after 4 weeks of Low FODMAP diet only, Low FODMAP diet + aerobic exercise, or Low FODMAP diet + vagus nerve stimulation). IBS-Symptom Severity Scale (IBS-SSS) will be administered at baseline and after 4 weeks.). 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 10 Jan 2025.