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

Starting soon · Early Phase 1

Conditions studied: Lower Gastrointestinal Disorder, Tolerance

In brief

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.

Key facts

Study ID

NCT07700277

Run by

Ottawa Hospital Research Institute

People needed

80

Starts

2026-08-01

Expected to finish

2027-12-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Willing and able to comply with study procedures, including timed dosing, required clear-fluid intake, and capsule preparation procedures for participants enrolled in Part III.
• Able to swallow solids, liquids, and pills without difficulty.

You may not qualify if…

• 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.
• Known or suspected gastrointestinal obstruction, bowel obstruction, ileus, bowel perforation, gastrointestinal perforation, or any condition associated with increased risk of obstruction or perforation.
• Acute abdominal or gastrointestinal condition in which bowel preparation may be unsafe, including acute surgical abdomen, acute appendicitis, gastroenteritis, diverticulitis, toxic colitis, toxic megacolon, severe colitis requiring urgent care, or another acute inflammatory, infectious, or structural gastrointestinal condition judged by the investigator to make participation unsafe.
• Known gastrointestinal ulceration or clinically significant active gastrointestinal bleeding, including unexplained rectal bleeding.
• Active nausea or vomiting at screening or before bowel preparation administration that, in the opinion of the investigator, would interfere with safe ingestion of the assigned capsule-based bowel preparation regimen.
• Emergency colonoscopy, including colonoscopy for lower gastrointestinal bleeding or any clinical condition requiring urgent endoscopic evaluation that would not allow adherence to the study bowel preparation protocol.
• Known hypersensitivity, allergy, or intolerance to Bi-PegLyte, Pico-Salax, bisacodyl, polyethylene glycol, sodium picosulfate, magnesium oxide, citric acid, electrolytes contained in the formulations, HPMC/hypromellose capsules, or any ingredient in the formulation or product container.
• Pregnancy or known or suspected pregnancy at screening or before bowel preparation administration.
• Capsule-specific feasibility or safety concern, including dysphagia, esophageal dysmotility, achalasia, esophageal stricture, high risk of aspiration, anatomical abnormality affecting swallowing, or any condition in which swallowing a large number of capsules is considered unsafe.
• Practical or adherence-related concern, including inability to follow timed dosing instructions, inability to comply with the required clear-fluid intake, lack of reliable contact, or anticipated nonadherence to study procedures.
• For Part III only: inability or unwillingness to self-prepare capsules using study-provided materials and instructions; inadequate manual dexterity or vision to prepare capsules safely and accurately; inability to complete the teach-back procedure, if required; or unwillingness to follow the standardized home preparation workflow, including use only of study-supplied materials, preparation within the defined time window, and storage as instructed.
• Any contraindication listed in the product monograph for Bi-PegLyte or Pico-Salax.

Full record on ClinicalTrials.gov

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