Lower Gastrointestinal DisorderEarly Phase 1CLEAR-CAPNCT07700277
A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
A Early Phase 1 study testing Sodium picosulfate, magnesium oxide, and citric acid capsules and Polyethylene glycol 3350 with electrolytes capsules in people with Lower Gastrointestinal Disorder and Tolerance, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Gastrointestinal Disorder, Tolerance
- What is being tested?
- Sodium picosulfate, magnesium oxide, and citric acid capsules and Polyethylene glycol 3350 with electrolytes capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules: Safety, Tolerability, Feasibility, and Preliminary Cleansing Effectiveness
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.
Read more
The main questions this study aims to answer are:
- Can participants swallow and complete a large number of bowel preparation capsules with the required clear fluids?
- Can the capsules be prepared accurately and practically by a pharmacy or by participants at home?
- Is the capsule-based bowel preparation safe and well tolerated?
- 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.
Read the detailed description
This is a prospective, single-site, open-label, sequential, non-randomized pilot feasibility study of capsule-based bowel preparation before colonoscopy.
The study will evaluate whether approved commercially available bowel preparation powders can be administered in vegan hydroxypropyl methylcellulose capsules instead of being mixed into a liquid solution before ingestion. The approved products used in this study are Pico-Salax and Bi-PegLyte. The active products, total approved dose, oral route, required clear-fluid intake, and split-dose timing will be preserved. The investigational aspect is the capsule-based method of administration.
The rationale for the study is that many people find liquid bowel preparation difficult to complete because of taste, texture, nausea, and the amount of liquid required. Capsule-based administration may reduce exposure to unpleasant taste and mouthfeel while maintaining the intended bowel cleansing effect, provided participants drink the required clear fluids.
The study will enroll adults aged 18 to 75 years who are scheduled for elective outpatient colonoscopy for screening, surveillance, or diagnostic indications and who have previously completed a conventional bowel preparation. Participants must be able to swallow solids, liquids, and pills without difficulty.
The study will proceed in three sequential parts:
In Part I, approximately 40 participants will receive Pico-Salax powder packaged in HPMC capsules prepared by a partner pharmacy. Twenty participants will receive size "000" capsules and 20 participants will receive size "00" capsules. This part will assess capsule ingestion completion, clear-fluid completion, swallowing acceptability, tolerability, safety, and bowel cleansing quality for the two capsule sizes.
After Part I, the study team will review tolerability, swallowing difficulty, capsule and fluid completion, safety findings, and bowel cleansing results. One capsule size will be selected for use in the later parts of the study.
In Part II, approximately 20 participants will receive Bi-PegLyte powder packaged in HPMC capsules prepared by the partner pharmacy using the capsule size selected after Part I. This part will assess whether a higher capsule-burden preparation is feasible and tolerated.
In Part III, approximately 20 participants will prepare the capsules themselves at home using study-supplied materials and written instructions. Ten participants will prepare Pico-Salax capsules and 10 participants will prepare Bi-PegLyte capsules. This part will assess whether participant-led home capsule preparation is practical, acceptable, and safe.
Across all parts, participants will take the capsule-based bowel preparation using a split-dose schedule before colonoscopy. Participants will drink the required clear fluids according to the study instructions. Participants assigned to Bi-PegLyte will take the bisacodyl tablets separately according to the usual regimen.
The primary outcomes are tolerability and feasibility. These include the proportion of participants who can ingest at least 80% of the prescribed capsules within the study dosing window, the proportion who complete the required clear-fluid intake, and the proportion who complete bowel preparation without stopping early because of capsule burden or swallowing difficulty. In the home-preparation part, feasibility will also include the proportion of participants who prepare at least 80% of the required capsules, preparation time, capsule count reconciliation, and participant-reported difficulty and confidence.
Secondary outcomes include participant-reported symptoms, adverse events, serious adverse events, clinically significant changes in electrolytes or creatinine, dehydration, emergency department presentation or hospitalization, and bowel cleansing quality at colonoscopy. Bowel cleansing will be assessed using the Boston Bowel Preparation Scale. Adequate bowel preparation is defined as a total score of at least 6 with no segment score below 2.
This pilot study is descriptive and is not designed for formal hypothesis testing. The results will help determine whether capsule-based bowel preparation is feasible, acceptable, and safe enough to support a future randomized controlled trial comparing capsule-based bowel preparation with standard liquid bowel preparation.
- Conditions
- Lower Gastrointestinal Disorder, Tolerance
- Being tested
- Sodium picosulfate, magnesium oxide, and citric acid capsules, Polyethylene glycol 3350 with electrolytes capsules
- Keywords
- Colonoscopy, Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium picosulfate, magnesium oxide, and citric acid capsulesDrug
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.
Polyethylene glycol 3350 with electrolytes capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium picosulfate, magnesium oxide, and citric acid capsules; Drug: Polyethylene glycol 3350 with electrolytes capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsule ingestion completion
Proportion of participants who ingest at least 80% of the prescribed bowel preparation capsules within the protocol-defined dosing window.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From capsule preparation through colonoscopy, up to 7 days
Secondary outcomes (13)
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.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
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.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Serious adverse events
Incidence of serious adverse events, including events requiring emergency department presentation, hospitalization, or urgent medical intervention.
Measured: From first capsule ingestion through 24 hours after colonoscopy
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.
Measured: Baseline within 1 week before bowel preparation and repeat assessment on the day of colonoscopy
Adequate bowel preparation by Boston Bowel Preparation Scale
Proportion of participants with adequate bowel preparation, defined as Boston Bowel Preparation Scale total score of at least 6 with no individual colon segment score below 2.
Measured: During colonoscopy on Day 0
Total Boston Bowel Preparation Scale score
Total Boston Bowel Preparation Scale score recorded during colonoscopy. Scores range from 0 to 9, with higher scores indicating better bowel cleansing.
Measured: During colonoscopy on Day 0
Cecal intubation rate
Proportion of participants in whom cecal intubation is achieved during colonoscopy.
Measured: During colonoscopy on Day 0
Need for rescue measures or early repeat colonoscopy
Proportion of participants requiring rescue bowel preparation measures, additional intraprocedural lavage due to inadequate cleansing, or recommendation for early repeat colonoscopy due to inadequate bowel preparation.
Measured: During colonoscopy on Day 0
Participant-reported nausea
Participant-reported nausea during capsule-based bowel preparation, assessed using the study-specific tolerability questionnaire. Nausea is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate worse nausea.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported overall tolerability
Participant-reported overall tolerability of capsule-based bowel preparation, assessed using the study-specific tolerability questionnaire. Overall tolerability is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate better tolerability.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported vomiting
Vomiting is assessed using the study-specific tolerability questionnaire. Vomiting is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate worse vomiting.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported abdominal discomfort
Abdominal discomfort is assessed using the study-specific tolerability questionnaire. Abdominal discomfort is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate worse abdominal discomfort.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported dizziness
Dizziness is assessed using the study-specific tolerability questionnaire. Dizziness is scored on a 5-point Likert scale from 1 to 5, where higher scores indicate worse dizziness.
Measured: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Gastrointestinal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700277
- Sponsor's protocol ID
- CLEAR-CAP
- Acronym
- CLEAR-CAP
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been determined. This is a small pilot feasibility study, and any future sharing of de-identified participant-level data would require review and approval by the sponsor-investigator and institutional policies, and would be conducted in accordance with applicable privacy, ethics, and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules: Safety, Tolerability, Feasibility, and Preliminary Cleansing Effectiveness
- ClinicalTrials.gov ID
- NCT07700277
- Acronym / sponsor ID
- CLEAR-CAP / CLEAR-CAP
- Conditions
- Lower Gastrointestinal Disorder, Tolerance
- Keywords
- Colonoscopy, Bowel preparation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can participants swallow and complete a large number of bowel preparation capsules with the required clear fluids?
- Can the capsules be prepared accurately and practically by a pharmacy or by participants at home?
- Is the capsule-based bowel preparation safe and well tolerated?
- 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.
Detailed description
This is a prospective, single-site, open-label, sequential, non-randomized pilot feasibility study of capsule-based bowel preparation before colonoscopy.
The study will evaluate whether approved commercially available bowel preparation powders can be administered in vegan hydroxypropyl methylcellulose capsules instead of being mixed into a liquid solution before ingestion. The approved products used in this study are Pico-Salax and Bi-PegLyte. The active products, total approved dose, oral route, required clear-fluid intake, and split-dose timing will be preserved. The investigational aspect is the capsule-based method of administration.
The rationale for the study is that many people find liquid bowel preparation difficult to complete because of taste, texture, nausea, and the amount of liquid required. Capsule-based administration may reduce exposure to unpleasant taste and mouthfeel while maintaining the intended bowel cleansing effect, provided participants drink the required clear fluids.
The study will enroll adults aged 18 to 75 years who are scheduled for elective outpatient colonoscopy for screening, surveillance, or diagnostic indications and who have previously completed a conventional bowel preparation. Participants must be able to swallow solids, liquids, and pills without difficulty.
The study will proceed in three sequential parts:
In Part I, approximately 40 participants will receive Pico-Salax powder packaged in HPMC capsules prepared by a partner pharmacy. Twenty participants will receive size "000" capsules and 20 participants will receive size "00" capsules. This part will assess capsule ingestion completion, clear-fluid completion, swallowing acceptability, tolerability, safety, and bowel cleansing quality for the two capsule sizes.
After Part I, the study team will review tolerability, swallowing difficulty, capsule and fluid completion, safety findings, and bowel cleansing results. One capsule size will be selected for use in the later parts of the study.
In Part II, approximately 20 participants will receive Bi-PegLyte powder packaged in HPMC capsules prepared by the partner pharmacy using the capsule size selected after Part I. This part will assess whether a higher capsule-burden preparation is feasible and tolerated.
In Part III, approximately 20 participants will prepare the capsules themselves at home using study-supplied materials and written instructions. Ten participants will prepare Pico-Salax capsules and 10 participants will prepare Bi-PegLyte capsules. This part will assess whether participant-led home capsule preparation is practical, acceptable, and safe.
Across all parts, participants will take the capsule-based bowel preparation using a split-dose schedule before colonoscopy. Participants will drink the required clear fluids according to the study instructions. Participants assigned to Bi-PegLyte will take the bisacodyl tablets separately according to the usual regimen.
The primary outcomes are tolerability and feasibility. These include the proportion of participants who can ingest at least 80% of the prescribed capsules within the study dosing window, the proportion who complete the required clear-fluid intake, and the proportion who complete bowel preparation without stopping early because of capsule burden or swallowing difficulty. In the home-preparation part, feasibility will also include the proportion of participants who prepare at least 80% of the required capsules, preparation time, capsule count reconciliation, and participant-reported difficulty and confidence.
Secondary outcomes include participant-reported symptoms, adverse events, serious adverse events, clinically significant changes in electrolytes or creatinine, dehydration, emergency department presentation or hospitalization, and bowel cleansing quality at colonoscopy. Bowel cleansing will be assessed using the Boston Bowel Preparation Scale. Adequate bowel preparation is defined as a total score of at least 6 with no segment score below 2.
This pilot study is descriptive and is not designed for formal hypothesis testing. The results will help determine whether capsule-based bowel preparation is feasible, acceptable, and safe enough to support a future randomized controlled trial comparing capsule-based bowel preparation with standard liquid bowel preparation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Capsule-Based Bowel Preparation | Experimental | Drug: Sodium picosulfate, magnesium oxide, and citric acid capsules, Drug: Polyethylene glycol 3350 with electrolytes capsulesParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium picosulfate, magnesium oxide, and citric acid capsulesPico-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 | Capsule-Based Bowel Preparation |
| Polyethylene glycol 3350 with electrolytes capsulesBi-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. | Drug | Capsule-Based Bowel Preparation |
Primary outcome
Capsule ingestion completion
Time frame: From first capsule ingestion through colonoscopy, approximately 24 hours
Proportion of participants who ingest at least 80% of the prescribed bowel preparation capsules within the protocol-defined dosing window.
Clear-fluid intake completion
Time frame: From first capsule ingestion through colonoscopy, approximately 24 hours
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
Time frame: From first capsule ingestion through colonoscopy, approximately 24 hours
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
Time frame: From capsule preparation through colonoscopy, up to 7 days
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.
13 secondary outcomes
Participant-reported swallowing difficulty
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Treatment-emergent adverse events
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Serious adverse events
Time frame: From first capsule ingestion through 24 hours after colonoscopy
Change in serum electrolytes and creatinine
Time frame: Baseline within 1 week before bowel preparation and repeat assessment on the day of colonoscopy
Adequate bowel preparation by Boston Bowel Preparation Scale
Time frame: During colonoscopy on Day 0
Total Boston Bowel Preparation Scale score
Time frame: During colonoscopy on Day 0
Cecal intubation rate
Time frame: During colonoscopy on Day 0
Need for rescue measures or early repeat colonoscopy
Time frame: During colonoscopy on Day 0
Participant-reported nausea
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported overall tolerability
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported vomiting
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported abdominal discomfort
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Participant-reported dizziness
Time frame: From first capsule ingestion through pre-procedure assessment on the day of colonoscopy, approximately 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been determined. This is a small pilot feasibility study, and any future sharing of de-identified participant-level data would require review and approval by the sponsor-investigator and institutional policies, and would be conducted in accordance with applicable privacy, ethics, and regulatory requirements.
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HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sodium picosulfate, magnesium oxide, and citric acid capsules and Polyethylene glycol 3350 with electrolytes capsules in people with Lower Gastrointestinal Disorder and Tolerance, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanjay K Murthy, MD (613-737-8899 ext. 73542, smurthy@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capsule ingestion completion (time frame: From first capsule ingestion through colonoscopy, approximately 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.