Mayo clinic tests Brain-Bowel retraining for constipation relief
NCT ID NCT07225803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study at Mayo Clinic tests whether biofeedback therapy and inspiratory muscle training can help people with dyssynergic defecation—a condition where pelvic floor muscles don't relax properly during bowel movements. Two hundred adults aged 18 to 80 with chronic constipation will learn to retrain their muscles using computer monitors and breathing exercises. The goal is to improve bowel emptying and reduce symptoms without medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- biofeedback therapy and inspiratory muscle training
- What this could lead to
- If successful, this could lead to better, non-drug treatments for chronic constipation caused by poor coordination of pelvic floor muscles.
- What could go wrong
- This is an early-stage behavioral study with no control group, so results may not prove the treatments work better than standard care. Success depends on patient effort and adherence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study * Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing Exclusion Criteria: * Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns. * History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted. * Current anal fissure * Clinically significant structural abnormalities (eg, rectocele \> 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms * Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation * Pregnant or nursing women, prisoners and institutionalized individuals * BMI \>35 kg/m2 * Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued them for at least 1 week before the date of screening and are willing to stay off them for the duration of the study. * Current use of anticholinergics (eg. amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline or amitriptyline up to 50 mg/day) will be eligible provided they do not increase the dose during the study period. Patients on higher doses are eligible to participate if it is safe and they are willing to reduce their medication dose at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete. * Current use of laxatives (Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete (As detailed later, all participants can use Miralax throughout the study). * Any other factors that increase the risk to participants of participating in the study and/or undermine the integrity of the data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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