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

NCT07700277 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: CLEAR-CAP
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Can participants swallow and complete a large number of bowel preparation capsules with the required clear fluids?
2. 2.Can the capsules be prepared accurately and practically by a pharmacy or by participants at home?
3. 3.Is the capsule-based bowel preparation safe and well tolerated?
4. 4.Does the capsule-based bowel preparation clean the bowel well enough for colonoscopy?

Conditions

Lower Gastrointestinal Disorder; Tolerance

Keywords

Colonoscopy; Bowel preparation

Outcome Measures

Primary Outcomes (4)

• Capsule ingestion completion

  Proportion of participants who ingest at least 80% of the prescribed bowel preparation capsules within the protocol-defined dosing window.

  From first capsule ingestion through colonoscopy, approximately 24 hours

• Clear-fluid intake completion

  Proportion of participants who complete the required clear-fluid intake according to the protocol-defined bowel preparation schedule.

  From first capsule ingestion through colonoscopy, approximately 24 hours

• 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.

  From first capsule ingestion through colonoscopy, approximately 24 hours

• 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.

  From capsule preparation through colonoscopy, up to 7 days

Secondary Outcomes (13)

• Participant-reported swallowing difficulty

  From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours

• Treatment-emergent adverse events

  From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours

• Serious adverse events

  From first capsule ingestion through 24 hours after colonoscopy

• Change in serum electrolytes and creatinine

  Baseline within 1 week before bowel preparation and repeat assessment on the day of colonoscopy

• Adequate bowel preparation by Boston Bowel Preparation Scale

  During colonoscopy on Day 0

Other Outcomes (7)

• Global satisfaction score for capsule-based bowel preparation

  From colonoscopy visit through post-procedure follow-up, within 24 to 72 hours after colonoscopy

• Participant-reported difficulty with home capsule preparation

  From home capsule preparation through post-procedure follow-up, within 24 to 72 hours after colonoscopy

• Willingness to repeat capsule-based bowel preparation

  From colonoscopy visit through post-procedure follow-up, within 24 to 72 hours after colonoscopy

Study Arms (1)

Capsule-Based Bowel Preparation

EXPERIMENTAL

Participants receive capsule-based bowel preparation before elective outpatient colonoscopy. The study is conducted sequentially in three parts: Part I evaluates centrally prepared Pico-Salax capsules using size "000" and size "00" HPMC capsules; Part II evaluates centrally prepared Bi-PegLyte capsules using the capsule size selected after Part I; and Part III evaluates participant-prepared Pico-Salax or Bi-PegLyte capsules at home using study-supplied materials and instructions. All regimens use approved marketed bowel preparation products at their approved dose with required clear-fluid intake and split-dose timing.

Drug: Sodium picosulfate, magnesium oxide, and citric acid capsules; Drug: Polyethylene glycol 3350 with electrolytes capsules

Interventions

Sodium picosulfate, magnesium oxide, and citric acid capsules DRUG

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.

Capsule-Based Bowel Preparation

Polyethylene glycol 3350 with electrolytes capsules DRUG

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.

Capsule-Based Bowel Preparation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Interventions

picosulfate sodium; Magnesium Oxide; Citric Acid; polyethylene glycol 3350; Electrolytes

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Sanjay K Murthy, MD

CONTACT

613-737-8899; smurthy@toh.ca

Abbey Corson, MSc

CONTACT

613-737-8899; acorson@ohri.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. No participants, care providers, investigators, or outcome assessors are masked to the assigned capsule-based bowel preparation regimen or study part.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential, non-randomized, open-label pilot feasibility study conducted in three parts. In Part I, participants receive centrally prepared Pico-Salax capsules using two capsule sizes. After descriptive review of tolerability, completion, safety, and bowel cleansing findings, one capsule size is selected for later parts. In Part II, participants receive centrally prepared Bi-PegLyte capsules using the selected capsule size. In Part III, participants prepare Pico-Salax or Bi-PegLyte capsules at home using study-supplied materials and instructions. There is no control group and no crossover.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07