Prevention of Radiotherapy-Induced Enteropathy by Probiotics (PREP): Double-Blind Randomized Placebo-Controlled Trial
Bibliographic record
Abstract
Probiotics are thought to be effective in the treatment of radiation-induced enteropathy (RIE). However, little is known regarding their efficacy in preventing RIE. In this prospective, randomized, double-blinded, placebo-controlled, single-center study, the incidence of grade 2 acute RIE was compared and the safety of probiotics was evaluated. Patients receiving pelvic radiotherapy for a minimum of 40 Gy at the pelvic level were randomized into two groups: (i) a probiotic group receiving Bacillus licheniformis from two weeks before radiotherapy until the end and (ii) a control group receiving a placebo with the same schedule. The toxicities of 234 patients were graded according to the Common Terminology Criteria for Adverse Events v5.0. Grade 1 RIE was observed in 65 (56%) of the probiotics group compared with 75 (64%) of the placebo group. Grade 2 RIE occurred in 30 patients (26%) in the probiotics group compared with 26 (22%) in the placebo group, indicating that probiotics failed in their preventive role compared with placebo (p = 0.493). Medication adherence rates were good, and no difference was observed between the two arms. These findings suggest that B. licheniformis does not significantly prevent RIE.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".