MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy

February 17, 2026 updated by: Yale University

Efficacy, Safety, and Tolerability of MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy: a Randomized Control Trial

Adequate bowel cleansing is a critical component in the care of hospitalized patients undergoing colonoscopy. However, inpatient status is a well-established risk factor for inadequate bowel preparation. However, few strategies have been rigorously shown to reduce the risk of inadequate bowel preparation. Moreover, inadequate bowel preparation is frequently related to the poor tolerability of high volumes of bowel preparation in the medically complex and comorbid hospitalized population. Low volume bowel preparations have been developed that have been shown to be noninferior compared to high volume bowel preparation with regards to adequacy of bowel preparation but with improved tolerability. However, the use of low volume bowel preparations for colonoscopies have largely been evaluated in the outpatient setting. In this study, we plan to compare rates of adequate bowel preparation and tolerability of a low volume bowel preparation, MoviPrep, compared to standard high volume bowel preparation, GoLYTELY, in hospitalized patients undergoing colonoscopy. This study promises to highlight low volume bowel preparation as a viable and better tolerated alternative to high volume bowel preparation in hospitalized patients which may ultimately decrease delays in inpatient endoscopy as well as hospital length of stay.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
520

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale New-Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 or greater
  4. Hospitalized patient scheduled to undergo colonoscopy with bowel preparation (not including preparation with enemas alone)
  5. Ability to take bowel preparation and be willing to adhere to the regimen

Exclusion Criteria:

  1. Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
  2. Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
  3. Patients with prior significant gastrointestinal surgeries including colonic resection, subtotal colectomy, abdomino-perineal resection, Hartmann's procedure or other similar surgeries involving structure/function of small intestine or colon
  4. Unable to give informed consent to the procedure
  5. Known glucose-6-phosphate dehydrogenase deficiency
  6. Known phenylketonuria
  7. Known hypersensitivity to polyethylene glycols or ascorbic acid
  8. Patients undergoing colonoscopy for foreign body removal and/or decompression
  9. Pregnancy or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MoviPrep

For MoviPrep, the dose, schedule, and route of administration are as follows:

  • On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
  • On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
  • Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
  • Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
Drug: MoviPrep
Split-dose MoviPrep bowel preparation
Active Comparator: GoLYTELY

For GoLYTELY, the dose, schedule, and route of administrate are as follows:

  • On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
  • Drink the remaining 2 liters on the morning of the procedure.
  • Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
  • Avoid red and purple liquids.
Drug: Golytely
Split-dose GoLYTELY bowel preparation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adequate Bowel Preparation
Time Frame: At time of procedure, approximately 45 minutes
The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2.
At time of procedure, approximately 45 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cecal Intubation Time
Time Frame: At time of procedure, approximately 45 minutes
Time from insertion of colonoscopy to reaching the cecum
At time of procedure, approximately 45 minutes
Colonoscopy Withdrawal Time
Time Frame: At time of procedure, approximately 45 minutes
Time from reaching the cecum to complete withdrawal of the colonoscope
At time of procedure, approximately 45 minutes
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment
Time Frame: At time of procedure, approximately 45 minutes
BBPS assesses three segments of the colon (left, transverse, right) and scores each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility.
At time of procedure, approximately 45 minutes
Number of Participants With "Excellent" Bowel Preparation
Time Frame: At time of procedure, approximately 45 minutes
The BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9.
At time of procedure, approximately 45 minutes
Cecal Intubation
Time Frame: At time of procedure, approximately 45 minutes
Number of participants with colonoscopies during which the cecum is successfully reached
At time of procedure, approximately 45 minutes
Time to Colonoscopy
Time Frame: From start of prep to time of procedure, up to 21 hours
The time from when the patient started the bowel preparation to the colonoscopy procedure itself.
From start of prep to time of procedure, up to 21 hours
Hospital Length of Stay
Time Frame: After study completion, an average of 10 days
Time from admission to discharge
After study completion, an average of 10 days
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: Through study completion, an average of 3 days
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity.
Through study completion, an average of 3 days
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "How tolerable did you find the bowel prep?"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Bad taste in mouth"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Gastric fullness"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Lack of sleep from excessive bathroom trips"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Nausea/vomiting"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Bloating/abdominal distension/gas"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Abdominal pain/cramps"
Immediately prior to procedure
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
Time Frame: Immediately prior to procedure

The Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy.

Data presented here is for "Headache"
Immediately prior to procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Darrick K Li, MD, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000031169
  • 000 (Other Identifier: CTGTY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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