The goal of this clinical trial is to learn whether bowel preparation powders used before colonoscopy can be taken as capsules instead of being mixed and drunk as a liquid. Bowel preparation is the medicine people take to clean the bowel before a colonoscopy.
This study will include adults aged 18 to 75 years who are already scheduled for an outpatient colonoscopy and who have had a colonoscopy before.
The main questions this study aims to answer are:
1. Can participants swallow and complete a large number of bowel preparation capsules with the required clear fluids? 2. Can the capsules be prepared accurately and practically by a pharmacy or by participants at home? 3. Is the capsule-based bowel preparation safe and well tolerated? 4. Does the capsule-based bowel preparation clean the bowel well enough for colonoscopy?
Participants will take approved bowel preparation products, Pico-Salax or Bi-PegLyte, in vegan hydroxypropyl methylcellulose capsules. They will take the capsules with clear fluids using a split-dose schedule before colonoscopy.
The study will happen in three parts. First, researchers will test two capsule sizes using Pico-Salax capsules prepared by a partner pharmacy. Then, researchers will test Bi-PegLyte capsules using the capsule size selected from the first part. Finally, some participants will prepare the capsules themselves at home using study instructions and materials.
Researchers will measure how many capsules and how much fluid participants complete, symptoms during preparation, safety blood tests, participant satisfaction, and bowel cleanliness during colonoscopy.
Age 18 to 75 years.
Scheduled for elective outpatient colonoscopy for a screening, surveillance, or diagnostic indication.
Has previously undergone colonoscopy using a conventional bowel preparation solution, without requiring repeat colonoscopy because of poor bowel preparation.
Able to provide informed consent.
Higher risk for clinically significant fluid or electrolyte shifts, including chronic renal impairment, severely reduced renal function, congestive cardiac failure, unstable cardiovascular disease, or any other condition in which large-volume fluid intake or rapid catharsis may be unsafe.
Baseline clinically significant electrolyte abnormalities.
Diabetes mellitus, gastroparesis, gastric retention, intestinal dysmotility, or any other condition that may impair gastric emptying, gastrointestinal transit, mixing, dissolution, or passage of the bowel preparation.
Current use of medications that may impair gastrointestinal motility or safe bowel preparation completion, including opioid medications, anticholinergic medications, or glucagon-like peptide-1 receptor agonists.
Sequential
Sodium picosulfate, magnesium oxide, and citric acid capsules
DrugPico-Salax powder for oral solution, containing sodium picosulfate, magnesium oxide, and citric acid, is transferred into vegan hydroxypropyl methylcellulose capsules and administered orally with required clear fluids using a split-dose bowel preparation schedule before colonoscopy. In Part I, Pico-Salax capsules are centrally prepared using size "000" and size "00" capsules. In Part III, participants prepare Pico-Salax capsules at home using the capsule size selected after Part I and study-supplied materials and instructions.
Polyethylene glycol 3350 with electrolytes capsules
DrugBi-PegLyte powder, containing polyethylene glycol 3350 with electrolytes, is transferred into vegan hydroxypropyl methylcellulose capsules and administered orally with required clear fluids using a split-dose bowel preparation schedule before colonoscopy. Bisacodyl tablets included in the approved Bi-PegLyte regimen are taken separately according to the usual regimen. In Part II, Bi-PegLyte capsules are centrally prepared using the capsule size selected after Part I. In Part III, participants prepare Bi-PegLyte capsules at home using study-supplied materials and instructions.
Capsule ingestion completion
Proportion of participants who ingest at least 80% of the prescribed bowel preparation capsules within the protocol-defined dosing window.
Clear-fluid intake completion
Proportion of participants who complete the required clear-fluid intake according to the protocol-defined bowel preparation schedule.
Completion without premature discontinuation due to capsule burden or swallowing difficulty
Proportion of participants who complete the capsule-based bowel preparation without stopping early because of capsule burden, swallowing difficulty, or intolerance related to capsule ingestion.
Capsule preparation feasibility
Feasibility of capsule preparation, including the proportion of participants in Part III who prepare at least 80% of required capsules, capsule count reconciliation relative to expected dose, time required for capsule preparation, and participant-reported difficulty and confidence in preparation accuracy.
Participant-reported swallowing difficulty
Participant-reported swallowing difficulty during capsule-based bowel preparation, assessed using the study-specific tolerability questionnaire. Swallowing difficulty is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate greater swallowing difficulty.
Treatment-emergent adverse events
Incidence and severity of treatment-emergent adverse events, including nausea, vomiting, abdominal pain, bloating, dizziness, dehydration, and other adverse events reported after capsule ingestion.
Serious adverse events
Incidence of serious adverse events, including events requiring emergency department presentation, hospitalization, or urgent medical intervention.
Change in serum electrolytes and creatinine
Change from baseline to post-bowel-preparation assessment in serum electrolytes and creatinine, including sodium, potassium, chloride, bicarbonate or total carbon dioxide, urea, and creatinine.
Global satisfaction score for capsule-based bowel preparation
Participant-reported global satisfaction with capsule-based bowel preparation, assessed using the study-specific satisfaction questionnaire. Global satisfaction is scored from 0 to 10, where higher scores indicate greater satisfaction.
Participant-reported difficulty with home capsule preparation
Among participants in Part III, participant-reported difficulty with preparing bowel preparation capsules at home, assessed using the study-specific questionnaire. Difficulty is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate greater difficulty.
Willingness to repeat capsule-based bowel preparation
Proportion of participants who report that they would be willing to use capsule-based bowel preparation again for a future colonoscopy.
Preference for capsule-based bowel preparation compared with prior liquid bowel preparation
Proportion of participants who report preferring capsule-based bowel preparation compared with their prior conventional liquid bowel preparation.
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