Fecal Incontinence
Conditions
Brief summary
Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.
Detailed description
Fecal incontinence, also known as accidental bowel leakage, is a common condition that is an immense burden to older women, caregivers, and the health care system. The overall goal of this study is to gather pilot data in order to conduct a future randomized controlled trial (RCT) for a novel treatment for fecal incontinence in older women utilizing fecal microbial transplantation (FMT). The investigator's hypothesis is that infusion of intestinal microbiota from healthy donors to older women with fecal incontinence will increase microbial diversity, reduce symptom severity, and improve quality of life. This study is a single arm, open-label clinical trial of FMT for the treatment of fecal incontinence refractory to conservative management. The investigators will measure the impact of FMT on change in symptom severity and quality of life and stool microbial diversity at 4 and 12 weeks after FMT.
Interventions
BIOLOGICALfecal microbial transplantation (FMT)
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women 50 years of age and older with self-reported fecal incontinence defined as: * Uncontrolled bothersome loss of liquid or solid fecal material that occurs at least weekly over the last 3 months and * Failure of response to conservative management using fiber, diet modification, supervised pelvic floor exercises * Baseline St. Mark's score of greater than or equal to 12 * Intolerance, unwillingness or inadequate response to constipating medications * Self-reported current negative colon cancer screening based on the 2016 US preventive Services Task Force recommendation (applies to participants age 50-75). N/A if participant is over 75 * Able and willing to sign the informed consent form and agree with study procedures
Exclusion criteria
* Known food allergy that could lead to anaphylaxis * Contraindications to naso-gastric tube placement including: * Recent mid-face trauma * History basilar skull fracture * Recent ENT surgery * Known coagulation abnormalities * Esophageal varices and/or esophageal strictures * Untreated prolapse beyond the hymen * History of Inflammatory Bowel Disease (does not include IBS) * Unrepaired rectovaginal fistula/chronic 4th degree laceration * Full thickness rectal prolapse * History of congenital anorectal malformation * History of bowel resection surgery for any indication * Minor anal procedures within 6 months for treatment of accidental bowel leakage (ABL) (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids * Prior pelvic or abdominal radiation * Diagnosis of cancer of the descending colon or anus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Show Significant Improvement at 4 Weeks After FMT, and Will be Maintained at 12 Weeks, Relative to Baseline Using the St. Mark's Vaizey Score, a Measure of Fecal Incontinence Severity. | 84 days | The St Marsk's Viazy score is a validated patient-reported instrument used to measure fecal incontinence severity. Score ranges from 0-24 with a decrease in the score representing an improvement. A subject has clinical improvement if they have demonstrated a sustained decrease of 4-5 points between the 4-week and 12-week measurements. |
| Count of Participants With Adverse Events. | 6 months | Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale. | 84 days | The FIQL is a valid and reliable 29-item questionnaire designed to evaluate the impact of FI on four aspects (domains) of patients' quality of life: lifestyle; coping behavior; depression or self-perception; and level of embarrassment. Domain scores range from 1-4 (higher scores indicating better quality of life). An improvement in the score of 1 (one) within each domain would indicate an improvement in the quality of life. |
| Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement. | 28 days | Concentration of Microbiota present at baseline vs at week 4 in subjects that demonstrate a significant improvement at 4 weeks after FMT, relative to baseline using the St. Mark's Vaizey score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation. | 28 days | Concentration of microbiota at baseline vs concentration of microbiota at 4 weeks. |
Countries
United States
Participant flow
Pre-assignment details
10 Subjects were enrolled. 2 subjects dropped out prior to administration of the investigational product. 8 subjects were treated with the investigational product.
Participants by arm
| Arm | Count |
|---|---|
| FMT Administration This is a single arm study in which all eligible participants will receive FMT.
fecal microbial transplantation (FMT): Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | FMT Administration |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 6 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Count of Participants With Adverse Events.
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT Administration | Count of Participants With Adverse Events. | 6 Participants |
Primary
Number of Subjects That Show Significant Improvement at 4 Weeks After FMT, and Will be Maintained at 12 Weeks, Relative to Baseline Using the St. Mark's Vaizey Score, a Measure of Fecal Incontinence Severity.
The St Marsk's Viazy score is a validated patient-reported instrument used to measure fecal incontinence severity. Score ranges from 0-24 with a decrease in the score representing an improvement. A subject has clinical improvement if they have demonstrated a sustained decrease of 4-5 points between the 4-week and 12-week measurements.
Time frame: 84 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT Administration | Number of Subjects That Show Significant Improvement at 4 Weeks After FMT, and Will be Maintained at 12 Weeks, Relative to Baseline Using the St. Mark's Vaizey Score, a Measure of Fecal Incontinence Severity. | 0 Participants |
Secondary
Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.
Concentration of Microbiota present at baseline vs at week 4 in subjects that demonstrate a significant improvement at 4 weeks after FMT, relative to baseline using the St. Mark's Vaizey score.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT Administration | Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement. | 0 Participants |
Secondary
Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.
The FIQL is a valid and reliable 29-item questionnaire designed to evaluate the impact of FI on four aspects (domains) of patients' quality of life: lifestyle; coping behavior; depression or self-perception; and level of embarrassment. Domain scores range from 1-4 (higher scores indicating better quality of life). An improvement in the score of 1 (one) within each domain would indicate an improvement in the quality of life.
Time frame: 84 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT Administration | Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale. | 0 Participants |
Other Pre-specified
Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation.
Concentration of microbiota at baseline vs concentration of microbiota at 4 weeks.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FMT Administration | Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation. | 0 Participants |