Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04159350
Eligibility Criteria:
Inclusion Criteria:
* individuals aged 18-80 with a body mass index of 18 to 40 kg/m2 and a primary ICD-10 diagnosis for constipation (K59\*) or referral for constipation.
* Does the patient meet Rome IV criteria for functional constipation (FC)?
* Does the patient report that fiber or laxative therapy has been ineffective to treat constipation in a documented treatment trial for at least two weeks prior to screening?
* Patient is already scheduled for anorectal manometry and physical therapy as part of routine care.
* The patient must agree to maintain their current dietary fiber intake and osmotic or bulk-forming laxative regimen (if any) throughout the trial
* The patient must agree to use stimulant laxatives (such as magnesium citrate \[Milk of Magnesia\], senna or bisacodyl \[Dulcolax\]) NO MORE THAN two days per week during the trial
* Patient must be able to participate in physical therapy for biofeedback
* Individuals must have health insurance coverage to undergo anorectal function testing and biofeedback therapy as part of their non-study routine clinical care
Exclusion Criteria:
* adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners, as they would be unable to reasonably comply with physical therapy within the duration of the study and would thus undergo unnecessary testing.
* Patient must NOT have tried biofeedback therapy or undergone anorectal manometry previously
* Patient must NOT report prior SURGERY involving the colon or rectum (including surgery for anal fissure, rectal prolapse)
* Patient must NOT recent opioid use within 30 days of enrollment
* Patient must NOT report a neurodegenerative condition (i.e. Parkinson's disease, dementia, multiple sclerosis, spinal cord injury) or uncontrolled inflammatory bowel disease
* Patient must NOT have used linaclotide (Linzess), lubiprostone (Amitiza), plecanatide (Trulance), tegaserod (Zelnorm) or prucalopride (Motegrity) within 30 days prior to enrollment. Patients MUST agree not to use these agents during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04159350
Study Brief:
Protocol Section:
NCT04159350