Fecal IncontinencePhase 1/2FMT for FINCT04201821
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
A Phase 1/2 study testing fecal microbial transplantation (FMT) in people with Fecal Incontinence, run by University of Pennsylvania at 1 site in United States.
Trial summary
Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- fecal microbial transplantation (FMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 18 Jan 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- fecal microbial transplantation (FMT)
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbial transplantation (FMT)Biological
Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
| Study group | Role | What they receive |
|---|---|---|
| FMT Administration | Experimental | This is a single arm study in which all eligible participants will receive FMT. Receives: Biological: fecal microbial transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 84 days
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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 84 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start14 Jan 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uduak U Andy, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201821
- Sponsor's protocol ID
- IRB# 834196
- Acronym
- FMT for FI
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2019
- Last updated
- 12 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
- ClinicalTrials.gov ID
- NCT04201821
- Acronym / sponsor ID
- FMT for FI / IRB# 834196
- Conditions
- Fecal Incontinence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT Administration | Experimental | Biological: fecal microbial transplantation (FMT)This is a single arm study in which all eligible participants will receive FMT. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal microbial transplantation (FMT)Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors. | Biological | FMT Administration |
Primary outcome
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.
Time frame: 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.
Time frame: 6 months
Frequency of adverse events, serious adverse events, and adverse events of special interest (including allergic reaction and gastrointestinal symptoms).
2 secondary outcomes
Number of Subjects That Have an Improved Quality of Life at 4 and 12 Weeks, Measured by the FIQL Scale.
Time frame: 84 days
Count of Participants That Demonstrate Microbial Engraftment Following Fecal Microbial Transplantation and Demonstrate Clinical Improvement.
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uduak U Andy, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fecal microbial transplantation (FMT) in people with Fecal Incontinence, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 84 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.