Interventional Bioremediation of Microbiota in Metabolic Syndrome
Model scores of the 29,894 trials active now.
Model score 17% 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 13% of the time (220 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-01-31, after 2016-06-30 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 2018-01-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: bowellymphocyticglucosecolitissyndrome
Phrases that lowered it: participantsfoodmgperiodalcohol -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 77 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past termination rate: 7.0% (lowers risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: 19.1% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Blinding: double (raises risk) · Design
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Sponsor's past trials: 228 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 84.7% (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 228 (typical: 32)
- Sponsor's past termination rate
- 7.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 77 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 36566 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6163 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- clindamycin, fecal microbiota, neomycin, vancomycin
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
- Transplantation of Microbes for Treatment of Metabolic Syndrome & NAFLD NCT02496390 · started 2016 · scored riskier than 35% of active trials completed
- Fecal Microbiota Transplantation for the Treatment of Obesity NCT02741518 · started 2017 · scored riskier than 48% of active trials completed
- Fecal Microbiota Transplantation in Pediatric Patients NCT02108821 · started 2014 · scored riskier than 40% of active trials completed
- FMT for MDRO Colonization After Infection in Renal Transplant Recipients NCT02922816 · started 2016 · scored riskier than 60% of active trials terminated
- Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans NCT02037295 · started 2014 · scored riskier than 26% 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.