Overview

Treating Anorectal Dysfunction in MS

Status:
Terminated

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

Summary

The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. Patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

David Levinthal
University of Pittsburgh

Collaborator:

Consortium of Multiple Sclerosis Centers

Treatments:

Bisacodyl

Criteria

Inclusion Criteria:

- MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale
[MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score
[EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of
MS disease modifying therapy, or comorbid medical condition AND who also have
anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.

Exclusion Criteria:

- MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or
equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal
anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric
infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative
proctitis, ulcerative colitis) will also be excluded.