Edible Colon Preparation Shows Excellent Efficacy, Safety and Tolerability in a Phase 2, Randomized Trial
Notice bibliographique
Résumé
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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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».