BloatingNCT05572606
Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol
A study testing Hypnotherapy in people with Bloating, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloating
- What is being tested?
- Hypnotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet Rome IV criteria for functional abdominal bloating/distension.
- Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
- Patients will be proficient in English language for comprehension of content.
- Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.
Who cannot join
- Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
- Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
- Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
- Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
- Patients with substance abuse disorders and drug addiction will be excluded.
- Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
Read the detailed description
This study consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.
- Conditions
- Bloating
- Being tested
- Hypnotherapy
- Keywords
- Hypnotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyBehavioural
Seven pre-recorded hypnotherapy sessions delivered over the course of twelve weeks via the patient's own electronic device such as a smartphone, tablet, or laptop. The length of the audio-recorded treatment sessions is expected to be approximately 40 minutes on average.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy for bloating symptoms | Experimental | Subjects experiencing bloating symptoms will receive hypnotherapy delivered electronically Receives: Behavioral: Hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal bloating severity
Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Measured: Baseline, 6 weeks, 12 weeks, and 3 months
Secondary outcomes (4)
Bloating symptoms
Assessed using the well validated upper GI symptom Severity Index (PAGI-SYM)
Measured: Baseline, 6 weeks, 12 weeks, and 3 months
Change in perception of GI symptoms
Measured using the self-reported Visceral Sensitivity Index (VSI)
Measured: Baseline, 6 weeks, 12 weeks, and 3 months
Change in quality of life
Assessed via the self-reported EuroQol-5D-5L (EQ-5D-5L) to evaluate mobility, self-care, usual activity, pain/discomfort, and anxiety/depression
Measured: Baseline, 6 weeks, 12 weeks, and 3 months
Health care utilization
Assessing the number of outpatient visits, portal messages, and procedures generated in three months
Measured: Baseline, 12 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start26 Jan 2023
- Primary completion1 Jan 2025
- 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 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Jing (Iris) Wang, Mayo Clinic
- Investigators
- Xiao Jing (Iris) Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572606
- Sponsor's protocol ID
- 22-005844
- Status last verified
- Oct 2025
- First submitted
- 5 Oct 2022
- Last updated
- 20 Oct 2025
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Delivery of a Novel Hypnotherapy Protocol for Treatment of Symptomatic Bloating
- ClinicalTrials.gov ID
- NCT05572606
- Acronym / sponsor ID
- 22-005844
- Conditions
- Bloating
- Keywords
- Hypnotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 7 Oct 2022 (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 research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.
Detailed description
This study consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy for bloating symptoms | Experimental | Behavioral: HypnotherapySubjects experiencing bloating symptoms will receive hypnotherapy delivered electronically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet Rome IV criteria for functional abdominal bloating/distension.
- Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
- Patients will be proficient in English language for comprehension of content.
- Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.
Key exclusion criteria (6 listed)
- Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
- Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
- Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
- Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
- Patients with substance abuse disorders and drug addiction will be excluded.
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 |
|---|---|---|
| HypnotherapySeven pre-recorded hypnotherapy sessions delivered over the course of twelve weeks via the patient's own electronic device such as a smartphone, tablet, or laptop. The length of the audio-recorded treatment sessions is expected to be approximately 40 minutes on average. | Behavioural | Hypnotherapy for bloating symptoms |
Primary outcome
Change in abdominal bloating severity
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Measured on a 0-100 scale using the bloating severity question of the the validated Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
4 secondary outcomes
Bloating symptoms
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Change in perception of GI symptoms
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Change in quality of life
Time frame: Baseline, 6 weeks, 12 weeks, and 3 months
Health care utilization
Time frame: Baseline, 12 weeks, and 3 months
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 20 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Bloating
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The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
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A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
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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.
Xiao Jing (Iris) Wang, 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 Hypnotherapy 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 4 inclusion and 6 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 20 Oct 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 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?
Change in abdominal bloating severity (time frame: Baseline, 6 weeks, 12 weeks, and 3 months). 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 20 Oct 2025.