Status:
WITHDRAWN
FMT as a Treatment for Severe Motility Disorder
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
OpenBiome
Conditions:
Severe Motility Disorder
Eligibility:
All Genders
3-50 years
Phase:
PHASE1
Brief Summary
Many patients that are treated with anorectal malformations are fecally incontinent for life. A Bowel Management Program has been developed to help these patients by creating a daily enema regimen to ...
Eligibility Criteria
Inclusion
- The study population to be enrolled in this study will include patients 18 years of age and older, with a Malone (appendicostomy) or with a cecostomy, that have received daily enemas for the treatment of fecal incontinence with prior good results for months to years. However, now these patients report not having an acceptable enema response (up to 4 hours for evacuation) despite numerous attempts to adjust the enema additives. The patients typically display a narrow, spastic left colon and a dilated right colon on contrast enema. A minimum of 10 adult subjects will be enrolled first and followed for safety and efficacy outcomes for at least one month. After the initial 10 adult subjects, there will be a pause in enrollment to allow for a formal review of the adult safety and efficacy data by the primary investigator. At this time a request will be made to open enrollment of this study up to the pediatric population as well as adults.
Exclusion
- Any patient who does not meet the above criteria will be excluded from this study. Also excluded: pregnant women, women of child-bearing potential who are unwilling to use an effective form of contraception for 30 days after FMT, women who are breastfeeding, subjects with end stage liver disease or cirrhosis, subjects with a life expectancy of less than 6 months, subjects with an absolute neutrophil count \<500 cells/µL and those with severe food allergies.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04373252
Start Date
July 1 2021
End Date
July 1 2021
Last Update
May 6 2022
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