Beneficial Bacteria Treatment for Autism
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (69 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
Completed on 2016-04-30, after 2014-07-31 start.
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 2016-04-30. 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: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: gastrointestinalscorechildrenautismbrain
Phrases that lowered it: trialto investigateclinicalopen labelsingle -
Phase: 1/2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 11.8% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 75.5% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 20882 (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 121934 (raises risk) · Drug's FDA history
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Minimum age: 7 (lowers risk) · Who can join
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Blinding: none (raises risk) · Design
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Responsible party: sponsor (raises risk) · Design
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Has a data monitoring committee: Yes (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 7 (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
- 24 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 121934 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20882 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- omeprazole, 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
- Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder NCT03514784 · started 2016 · scored riskier than 8% of active trials completed
- The Use of VSL#3 in Irritable Bowel Syndrome in Children NCT00932841 · started 2008 · scored riskier than 84% of active trials terminated
- Micronutrient Supplementation in Children With ASD NCT05268744 · started 2022 · scored riskier than 56% of active trials completed
- Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA) NCT03887676 · started 2019 · scored riskier than 25% of active trials completed
- A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study) NCT02410902 · started 2015 · scored riskier than 13% 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.