Trial Outcomes & Findings for Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women (NCT NCT04201821)
NCT ID: NCT04201821
Last Updated: 2024-06-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
84 days
Results posted on
2024-06-12
Participant Flow
10 Subjects were enrolled. 2 subjects dropped out prior to administration of the investigational product. 8 subjects were treated with the investigational product.
Participant milestones
| Measure |
FMT Administration
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
FMT Administration
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
Baseline characteristics by cohort
| Measure |
FMT Administration
n=8 Participants
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.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 84 daysThe 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.
Outcome measures
| Measure |
FMT Administration
n=8 Participants
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
|
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
|
PRIMARY outcome
Timeframe: 6 monthsFrequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
Outcome measures
| Measure |
FMT Administration
n=8 Participants
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
|
Count of Participants With Adverse Events.
|
6 Participants
|
SECONDARY outcome
Timeframe: 84 daysThe 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.
Outcome measures
| Measure |
FMT Administration
n=8 Participants
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
|
Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysConcentration 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.
Outcome measures
| Measure |
FMT Administration
n=8 Participants
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
|
Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysConcentration of microbiota at baseline vs concentration of microbiota at 4 weeks.
Outcome measures
| Measure |
FMT Administration
n=8 Participants
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
|
Count of Participants That Demonstrate Engraftment Following Fecal Microbial Transplantation.
|
0 Participants
|
Adverse Events
FMT Administration
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FMT Administration
n=8 participants at risk
This is a single arm study in which all eligible participants will receive FMT.
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
|
|---|---|
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Gastrointestinal disorders
Abdominal Bloating
|
12.5%
1/8 • Number of events 3 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
2/8 • Number of events 3 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Belching
|
12.5%
1/8 • Number of events 4 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 6 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Number of events 10 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 4 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
37.5%
3/8 • Number of events 3 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
General disorders
General Disorder and administrative site conditions - Other - nasal irritation
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
General disorders
General disorders and administration site conditions - Other - nostril pain
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 2 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
50.0%
4/8 • Number of events 4 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
37.5%
3/8 • Number of events 3 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
|
Vascular disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reactions and gastrointestinal symptoms)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place