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

Summary

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.

Conditions

• Lower Gastrointestinal Disorder
• Tolerance

Interventions

DRUG

Sodium picosulfate, magnesium oxide, and citric acid capsules

Pico-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.

DRUG

Polyethylene glycol 3350 with electrolytes capsules

Bi-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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute

  lead OTHER

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-08-01

Completion

2027-12-30