Clinical trial NCT04373252: FMT as a Treatment for Severe Motility Disorder
Official title: Fecal Microbiota Transplant as a Treatment for Severe Motility Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Severe Motility Disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: OpenBiome
First posted: 2020-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 keep them artificially clean of stool in the underwear. Due to the high success rate of the program, many patients who suffer from fecal incontinence due to other reasons such as, spina bifida, sacrococcygeal teratoma and sacral agenesis are referred to the program. A new issue is emerging with a group of patients that no longer obtain effective results from their daily enemas, even though they have worked successfully for years. These same patients are presenting with a narrow, spastic left colon and remarkably dilated right colon. Our hypothesis is that prolonged enema administration negatively impacts the microbiota of the colon causing the lack of response from enema administration. The purpose of this study is to restore the normal flora of the colon by fecal microbiota transplant (FMT) which we believe will improve responsiveness to enemas. By restoring colonic flora, patients will again become responsive to daily enemas and regain successful bowel management.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Patients become responsive to daily enema treatments again
timeFrame: 1 year
Secondary outcomes:
measure: Microbiota Analysis
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Andrea Bischoff, MD
role: PRINCIPAL_INVESTIGATOR
References: