Results From a Proof of Concept Study Evaluating DCL-101, a Novel Pill Colon Prep, Compared to 4L PEG-ELS in Adult Outpatients Undergoing Routine Colonoscopy
Bibliographic record
Abstract
Introduction: The dissolved powder in polyethylene glycol-electrolyte lavage solutions (PEG-ELS) used for colonoscopy bowel preparation is composed of approximately 10% salts and 90% PEG3350. The 10% salts confer the bad taste commonly experienced by patients using PEG-ELS, whereas PEG3350 is tastefree at concentrations used in most PEG-ELS solutions. DCL-101, a novel Pill Prep, is compositionally identical to standard 4L PEG-ELS, but delivers the salt by capsule, with the PEG3350 co-administered as a taste-free oral solution. The primary objective of this Phase 2 Study was to compare the safety, taste and tolerability of split dose DCL-101 to split dose 4L PEG-ELS in preparing the colon for colonoscopy, with a secondary objective to assess bowel cleansing. Methods: This was a multicenter, randomized, investigator-blinded, non-inferiority Phase 2 clinical trial. 45 adult patients undergoing routine outpatient colonoscopy were randomized 2:1 to receive either DCL-101 (3L in Cohort 1 vs. 4L in Cohort 2) or 4L PEG-ELS, each administered with split dosing. Tolerability was measured using the Lawrance Bowel-Preparation Tolerability Questionnaire and the Mayo Clinic Bowel Prep Tolerability Questionnaire. Efficacy was determined by expert central readers, blinded to treatment, on the Ottawa Bowel Preparation Quality Scale (OBPQS) and Boston Bowel Preparation Scale (BBPS). Weight, orthostatic blood pressure, and laboratory parameters were measured during the study. Data was analyzed using ANOVA, Fisher’s exact, and Cochran-Armitage trend tests. Results: Safety and tolerability were demonstrated. All subjects were able to self-administer DCL-101 without difficulty. There were no Serious Adverse Events or episodes of orthostatic hypotension. No significant differences were seen in adverse events between the 3 treatment regimens. No patients rated DCL-101 as less than acceptable tolerability. Both DCL-101 doses had superior taste (Figure 1) and tolerability (Figures 2 and 3) relative to PEG-ELS 4L. Efficacy was demonstrated. There were no significant differences among the 3 treatments as defined by either the centrally read OBPQS or BBPS. There were no inadequate preps as judged by the site endoscopist.205_A Figure 1 No Caption available.205_B Figure 2 No Caption available.205_C Figure 3 No Caption available.Conclusion: 1. DCL-101 Pill Prep is a novel strategy that vastly improves the taste and tolerability of PEG-ELS solutions. 2. DCL-101, even at a 4L dose, is significantly more tolerable than 4L PEG-ELS, with an identical composition. 3. DCL-101 demonstrates comparable safety and efficacy as 4L PEG-ELS.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 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".