Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation

Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01398020

Enrollment

318

Registered

2011-07-20

Start date

2011-07-31

Completion date

2013-09-30

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ease of Bowel Preparation and Patient Tolerability, Efficacy of Bowel Preparation

Keywords

Bowel Preparation, Patient comfort, Bi-Peglyte

Brief summary

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.

Interventions

DRUGStandard Bowel Prep

Subjects will be asked to take 4L of Peglyte the day prior to procedure.

DRUG2L Bi-Peglyte Bowel Prep

Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 19 or older * Outpatient colonoscopy

Exclusion criteria

* constipation

Design outcomes

Primary

Measure	Time frame	Description
Difference in Boston Bowel Preparation Scale between the two groups	30 minutes	This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.

Secondary

Measure	Time frame	Description
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups	20 hours	Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.	20	Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026