Edible Colon Preparation Shows Excellent Efficacy, Safety and Tolerability in a Phase 2, Randomized Trial
Bibliographic record
Abstract
Introduction: Approximately 40% of people for whom a screening colonoscopy is indicated do not undergo the procedure. A top reason cited for not having a colonoscopy is the preparation required before the procedure. Advances are needed to develop a better preparation to improve patients' ease and willingness to undergo colonoscopy. The aim of this study was to test the efficacy, safety and tolerability of a patient-centered, physician-formulated meal kit for colonoscopy preparation to determine the lead formulation to bring into a phase 3 study. Methods: We performed a phase 2, dual-center, randomized, single blind study of Edible Colon Prep (ECP) for bowel cleansing prior to colonoscopy. We tested six formulations of ECP, using different doses of the active ingredients integrated within different meal kit menus in an adaptive design randomized against two FDA approved active comparators. The primary outcome was the proportion of subjects with an endoscopic visibility rating of excellent or good based on the Aronchick scale. Secondary endpoints included segment-by-segment endoscopic visibility based on the Ottawa scale, in addition to safety, tolerability and reports of patients' experience.Figure 1Results: Fifty-one subjects were treated with ECP, and 14 with active comparators. All subjects were between the ages of 40 and 75, had a prior colonoscopy and were undergoing colonoscopy for colon cancer screening or surveillance. Demographics were similar between groups, and subjects dosed with ECP had a median age of 62 and 55% were female. In our top three most effective candidate formulations of ECP, 90.6% (29 of 32) of subjects had a rating of excellent or good. With our lead formulation, 93.3% (14 of 15) of patients undergoing colonoscopies had a rating of excellent or good with 40 of 45 (88.9%) colon segments rated as excellent or good on the Ottawa scale. For the comparators, 85.7% (12 of 14) had a rating of excellent or good on the Aronchick scale. There were no serious adverse events across any of the treatment groups. 64.3% of subjects taking the lead formulation reported being satisfied or extremely satisfied with the experience of the preparation as compared to 33.3% of the comparators. Conclusion: ECP appears at least as effective and safe as currently available colonoscopy preparation formulations. In addition, patients preferred ECP with high satisfaction of the preparation experience.
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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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".