IBS - Irritable Bowel SyndromeNCT04225104
Yogic Breathing and IBS
A study testing Yogic breathing intervention in people with IBS - Irritable Bowel Syndrome, run by Texas State University at 1 site in United States.
Trial summary
Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Yogic breathing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 1 Mar 2020
- 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
- Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.
Who cannot join
- 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS
Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Yogic breathing intervention
- 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.
Yogic breathing interventionBehavioural
Yogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor.
| Study group | Role | What they receive |
|---|---|---|
| Yogic breathing intervention | Experimental | Participants assigned to this group will complete a 20-minute yogic breathing video at least 5 days per week for 4 weeks. All sessions except the initial yogic breathing session will be completed at home. Participants will complete the first session at Texas State under the supervision of the investigative team for familiarization. Receives: Behavioral: Yogic breathing intervention |
| Control | No intervention | Participants in the control group will be asked to maintain their current daily activities and will be given access to the yogic breathing video once all follow-up testing has been completed at the end of week 4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptoms
IBS-Symptom Severity Scale will be administered.
Measured: Once at baseline
IBS Symptoms
IBS-Symptom Severity Scale will be administered.
Measured: Once at the end of week 2
IBS Symptoms
IBS-Symptom Severity Scale will be administered.
Measured: Once at the end of week 4
Autonomic function
Heart rate variability will be assessed.
Measured: Once at baseline
Autonomic function
Heart rate variability will be assessed.
Measured: Once at the end of week 2
Autonomic function
Heart rate variability will be assessed.
Measured: Once at the end of week 4
Autonomic function
Exercise heart rate recovery will be measured.
Measured: Once at baseline
Autonomic function
Exercise heart rate recovery will be measured.
Measured: Once at the end of week 2
Autonomic function
Exercise heart rate recovery will be measured.
Measured: Once at the end of week 4
Microvascular function
Laser Doppler flowmetry at baseline and in response to local heating will be measured.
Measured: Once at baseline
Microvascular function
Laser Doppler flowmetry and in response to local heating will be measured.
Measured: Once at the end of week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start15 Apr 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy D Hunter, PhD, Principal investigator, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225104
- Sponsor's protocol ID
- 6275
- Status last verified
- Mar 2021
- First submitted
- 7 Jan 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katherine Jurek M, Seavey H, Guidry M, Slomka E, Hunter SD. The effects of slow deep breathing on microvascular and autonomic function and symptoms in adults with irritable bowel syndrome: A pilot study. Neurogastroenterol Motil. 2022 May;34(5):e14275. doi: 10.1111/nmo.14275. Epub 2021 Oct 1.
PubMed 34595801
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yogic Breathing on Microvascular Endothelial Function and Symptoms in Participants With IBS
- ClinicalTrials.gov ID
- NCT04225104
- Acronym / sponsor ID
- 6275
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Jan 2020 (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.
Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogic breathing intervention | Experimental | Behavioral: Yogic breathing interventionParticipants assigned to this group will complete a 20-minute yogic breathing video at least 5 days per week for 4 weeks. All sessions except the initial yogic breathing session will be completed at home. Participants will complete the first session at Texas State under the supervision of the investigative team for familiarization. |
| Control | No intervention | –Participants in the control group will be asked to maintain their current daily activities and will be given access to the yogic breathing video once all follow-up testing has been completed at the end of week 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.
Key exclusion criteria (1 listed)
- 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary 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 |
|---|---|---|
| Yogic breathing interventionYogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor. | Behavioural | Yogic breathing intervention |
Primary outcome
IBS Symptoms
Time frame: Once at baseline
IBS-Symptom Severity Scale will be administered.
IBS Symptoms
Time frame: Once at the end of week 2
IBS-Symptom Severity Scale will be administered.
IBS Symptoms
Time frame: Once at the end of week 4
IBS-Symptom Severity Scale will be administered.
Autonomic function
Time frame: Once at baseline
Heart rate variability will be assessed.
Autonomic function
Time frame: Once at the end of week 2
Heart rate variability will be assessed.
Autonomic function
Time frame: Once at the end of week 4
Heart rate variability will be assessed.
Autonomic function
Time frame: Once at baseline
Exercise heart rate recovery will be measured.
Autonomic function
Time frame: Once at the end of week 2
Exercise heart rate recovery will be measured.
Autonomic function
Time frame: Once at the end of week 4
Exercise heart rate recovery will be measured.
Microvascular function
Time frame: Once at baseline
Laser Doppler flowmetry at baseline and in response to local heating will be measured.
Microvascular function
Time frame: Once at the end of week 4
Laser Doppler flowmetry and in response to local heating will be measured.
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 6 Aug 2021.
- Derived from this study: PubMed 34595801Katherine Jurek M, Seavey H, Guidry M, Slomka E, Hunter SD. The effects of slow deep breathing on microvascular and autonomic function and symptoms in adults with irritable bowel syndrome: A pilot study. Neurogastroenterol Motil. 2022 May;34(5):e14275. doi: 10.1111/nmo.14275. Epub 2021 Oct 1.
- Individual participant dataSharing planned: No
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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.
Stacy D Hunter, PhD principal investigator
Texas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogic breathing intervention in people with IBS - Irritable Bowel Syndrome, run by Texas State University at 1 site in United States.
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 1 inclusion and 1 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 6 Aug 2021. 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 States. 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?
IBS Symptoms (time frame: Once at baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225104, which also lists 1 linked publication.
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 6 Aug 2021.