Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 7% 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
Terminated on 2020-07-21, after 2019-04-11 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 2020-07-21. 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: chronicacuterandomizationhealthyenrollment
Phrases that lowered it: upperparticipantpatientschemotherapyaccording -
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
-
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports with a death: 34.5% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Maximum age: 5 (raises risk) · Who can join
-
Minimum age: 1 (lowers risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
-
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
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 5 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 2 (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
- 29 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 34.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- fecal microbiota
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
- Therapeutic Approaches to Malnutrition Enteropathy NCT03716115 · started 2020 · scored riskier than 32% 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
- Sentinel Cohort REACT NCT05780801 · started 2023 · scored riskier than 81% of active trials completed
- Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old NCT03474276 · started 2018 · scored riskier than 5% of active trials completed
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM NCT05994742 · started 2024 · scored riskier than 19% 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.