BloatingNCT06596759
Diaphragmatic Breathing for the Treatment of Bloating and Distension
A study testing Diaphragmatic Breathing in people with Bloating, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bloating
- What is being tested?
- Diaphragmatic Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referred for breath testing for the indication of bloating.
Who cannot join
- Not referred for breath testing for the indication of bloating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Brian E Lacy
About this study
Official title: Diaphragmatic Breathing for the Treatment of Bloating and Distension: a Prospective Pilot Study
The purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.
- Conditions
- Bloating
- Being tested
- Diaphragmatic Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingBehavioural
REDCap will be used to administer the Mayo Bloating Questionnaire (MBQ) and collect self-reported compliance to diaphragmatic breathing (DB) exercises over a 4 week follow up period. After completion of the MBQ, the patient will be taught DB techniques by an individual physical therapist face to face over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. Patients will receive a telephone call and electronic health record portal message to check progress and answer any questions. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing. The questionnaire will include prompts investigating perceived side effects and attitudes towards therapy, willingness to perform DB therapy, likelihood to attempt self-guided DB in the future, and if the participant would recommend the therapy to a friend.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Patients will complete the Mayo Bloating Questionnaire (MBQ) before referral to a physical therapist for in diaphragmatic breathing (DB) techniques over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing. Receives: Behavioral: Diaphragmatic Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo Bloating Questionnaire (MBQ) score
The Mayo Bloating Questionnaire is a 45-item questionnaire developed to measure the multiple symptom components of bloating and distension.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloatingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Lacy, Mayo Clinic
- Investigators
- Brian E Lacy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596759
- Sponsor's protocol ID
- 24-002905
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Breathing for the Treatment of Bloating and Distension: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06596759
- Acronym / sponsor ID
- 24-002905
- Conditions
- Bloating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this study is to evaluate the efficacy of diaphragmatic breathing using the validated Mayo Bloating Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing | Experimental | Behavioral: Diaphragmatic BreathingPatients will complete the Mayo Bloating Questionnaire (MBQ) before referral to a physical therapist for in diaphragmatic breathing (DB) techniques over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for breath testing for the indication of bloating.
Key exclusion criteria (1 listed)
- Not referred for breath testing for the indication of bloating.
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 |
|---|---|---|
| Diaphragmatic BreathingREDCap will be used to administer the Mayo Bloating Questionnaire (MBQ) and collect self-reported compliance to diaphragmatic breathing (DB) exercises over a 4 week follow up period. After completion of the MBQ, the patient will be taught DB techniques by an individual physical therapist face to face over a 30-minute session. The patient will be instructed to complete 5-10 minutes of diaphragmatic breathing twice a day for a period of 4 weeks. Patients will receive a telephone call and electronic health record portal message to check progress and answer any questions. At the end of the 4-week follow up period, patients will repeat the MBQ and self-report their adherence to daily diaphragmatic breathing. The questionnaire will include prompts investigating perceived side effects and attitudes towards therapy, willingness to perform DB therapy, likelihood to attempt self-guided DB in the future, and if the participant would recommend the therapy to a friend. | Behavioural | Diaphragmatic Breathing |
Primary outcome
Change in Mayo Bloating Questionnaire (MBQ) score
Time frame: Baseline, 4 weeks
The Mayo Bloating Questionnaire is a 45-item questionnaire developed to measure the multiple symptom components of bloating and distension.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- 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.
Brian E Lacy, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing in people with Bloating, run by Mayo Clinic 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert C Chase, MD (904-953-2000, chase.robert@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mayo Bloating Questionnaire (MBQ) score (time frame: Baseline, 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 4 Jun 2026.