Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 5% 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 (137 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-06-09, after 2020-06-22 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 2023-06-09. 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
-
Sponsor's past termination rate: 15.2% (raises risk) · Sponsor's track record
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Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: celldiseasechronichighage
Phrases that lowered it: effect ofthe effectasthmaparticipantsallergy -
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 98 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 362 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 79.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 29 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 11 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 362 (typical: 32)
- Sponsor's past termination rate
- 15.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 98 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 29 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- butyrate, starch
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
- Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber) NCT04209075 · started 2020 · scored riskier than 11% of active trials completed
- Lactobacillus Johnsonii Supplementation in Adults With T1D NCT03961347 · started 2020 · scored riskier than 53% of active trials completed
- Lactobacillus Johnsonii in Children and Adolescents With T1D NCT03961854 · started 2019 · scored riskier than 56% of active trials completed
- Interventional Bioremediation of Microbiota in Metabolic Syndrome NCT02730962 · started 2016 · scored riskier than 56% of active trials terminated
- Butyrate Adjuvant Therapy for Type 1 Diabetes NCT03999853 · started 2022 · scored riskier than 50% 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.