Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (136 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-01-27, after 2016-05-31 start.
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 2021-01-27. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: transplanttherapyrandomizationdonorend
Phrases that lowered it: agedtwicetrialdailydose -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 13.5% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 10.2% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 14 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 74 (typical: 32)
- Sponsor's past termination rate
- 13.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 40551 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8313 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- doxycycline, metronidazole, terbinafine
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
- Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis NCT03006809 · started 2017 · scored riskier than 35% of active trials completed
- Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis NCT02227342 · started 2014 · scored riskier than 86% of active trials completed
- A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis NCT02058524 · started 2013 · scored riskier than 25% of active trials terminated
- Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis NCT04434872 · started 2015 · scored riskier than 24% of active trials terminated
- Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis NCT03998488 · started 2020 · scored riskier than 36% 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.