A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sodium picosulfate, magnesium oxide, and citric acid capsules
  • Polyethylene glycol 3350 with electrolytes capsules

Treatment groups

80 Participants
are divided into 1 treatment group

Locations

This trial has no locations