Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (785 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2016-07-31, after 2015-07-31 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-07-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: therapytransplantationpatientstreatingdonor
Phrases that lowered it: healthyeffectassessvisitblood -
Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 55.6% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 49 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 32
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 49 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 9 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 55.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- fecal microbiota
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Fecal Transplant for Ulcerative Colitis NCT03948919 · started 2019 · scored riskier than 60% of active trials completed
- Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) NCT02516384 · started 2016 · scored riskier than 76% of active trials completed
- Fecal Transplantation for Inflammatory Bowel Disease NCT02391012 · started 2015 · scored riskier than 41% of active trials terminated
- A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis NCT02058524 · started 2013 · scored riskier than 25% of active trials terminated
- Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis NCT03006809 · started 2017 · scored riskier than 35% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.