MAPP Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS (NCT01280864) | Clinical Trial Compass
TerminatedNot Applicable
MAPP Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS
Stopped: the study PI left the university of iowa
United States36 participantsStarted 2010-03
Plain-language summary
Hypotheses:
1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical evoked potentials and efferent cortically-induced (magnetic) anorectal motor evoked potentials.
2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal visceral hypersensitivity and anorectal sensory-motor dysfunction.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. During the previous year, all patients must have recurrent abdominal discomfort or pain for at least 3 days per month in the last 3 months associated with two or more of the following symptoms (6): i) improvement with defecation; ii) onset associated with a change in frequency of stool; and/or iii) onset associated with a change in form (appearance) of stool (83);
. No evidence for structural diseases (excluded by colonoscopy/ barium enema and metabolic problem by lab tests; and
. On a prospective symptom/stool diary \[Appendix 1\] patients reported i) presence of abdominal pain/discomfort for at least 2 days per week; ii) hard or lumpy stools \>25% and loose or watery stools in \< 25% of bowel movements (IBS-C); (iii) loose or watery stools in \>25% of bowel movements and hard stools \<25% of BMs(IBS-D); \>25% of hard or loose stools within one week (IBS-M) (6).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with laxative abuse, anorexia nervosa, and bulimia;
. Patients taking constipating drugs, (e.g. opioids), tricyclics (because of increased seizure risk), serotonin modulators (tegaserod), antispasmodics (dicyclomine or hyoscyamine), muscle relaxants (e.g. cyclobenzaprine) unless the drug is stopped at least 2 weeks before enrollment;
. Patients with a current history of depression and/or taking antidepressants;
. Patients with comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
. Patients with neurologic diseases (e.g. head injuries, epilepsy, multiple sclerosis, strokes, spinal cord injuries) or brain disorders prone to causing seizures;