Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (53 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2012-10-31, after 2010-06-30 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-10-31. 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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Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: associatedpatientchronicplacebo controlledcatheter
Phrases that lowered it: patientsdays beforeadultreceiveclinical trials -
Drug's FAERS reports with a death: 50% (raises risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: prevention (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 75% (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: 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
- 6 (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
- government (typical: academic or other)
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 50% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 4 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75% (typical: 85.6%)
- Drug's FAERS reports with a death
- 50% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- cellulose
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
- Saccharomyces Boulardii in Irritable Bowel Syndrome NCT00589771 · started 2010 · scored riskier than 20% of active trials completed
- Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults. NCT04321460 · started 2020 · scored riskier than 10% of active trials completed
- Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea NCT00973908 · started 2010 · scored riskier than 17% of active trials completed
- A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients. Estudo PROICA NCT01500343 · started 2008 · scored riskier than 42% of active trials completed
- Prevention of Irinotecan Induced Diarrhea by Probiotics NCT02819960 · started 2016 · scored riskier than 34% 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.