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 range18 Years
SexALL
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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
✕. 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;