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Bowel Preparation Before ColonoscopyPhase 4NCT05054036

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

A Phase 4 study testing MoviPrep and Golytely in people with Bowel Preparation Before Colonoscopy, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bowel Preparation Before Colonoscopy
What is being tested?
MoviPrep and Golytely
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
2 sitesUnited States
Study dates
12 Jan 2022to 1 Jul 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients presenting to the hospital with ileus, toxic megacolon, evidence of gastrointestinal obstruction
  • Receipt of bowel preparation for other reasons during their hospitalization prior to their colonoscopy
  • 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
  • Unable to give informed consent to the procedure
  • Known glucose-6-phosphate dehydrogenase deficiency
  • Known phenylketonuria
Show all 9Show fewer
  • Known hypersensitivity to polyethylene glycols or ascorbic acid
  • Patients undergoing colonoscopy for foreign body removal and/or decompression
  • Pregnancy or lactating women

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Yale New-Haven Hospital

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: 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.

Being tested
MoviPrep, Golytely
Keywords
colonoscopy, bowel preparation, inpatient, tolerability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoviPrepDrug

    Split-dose MoviPrep bowel preparation

  • GolytelyDrug

    Split-dose GoLYTELY bowel preparation

Study groups in NCT05054036
Study groupRoleWhat they receive
MoviPrepExperimentalFor 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.
Receives: Drug: MoviPrep
GoLYTELYActive comparatorFor 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.
Receives: Drug: Golytely

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adequate Bowel Preparation

    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.

    Measured: At time of procedure, approximately 45 minutes

Secondary outcomes (18)
  1. Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment

    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.

    Measured: At time of procedure, approximately 45 minutes

  2. Number of Participants With "Excellent" Bowel Preparation

    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.

    Measured: At time of procedure, approximately 45 minutes

  3. Cecal Intubation

    Number of participants with colonoscopies during which the cecum is successfully reached

    Measured: At time of procedure, approximately 45 minutes

  4. Cecal Intubation Time

    Time from insertion of colonoscopy to reaching the cecum

    Measured: At time of procedure, approximately 45 minutes

  5. Colonoscopy Withdrawal Time

    Time from reaching the cecum to complete withdrawal of the colonoscope

    Measured: At time of procedure, approximately 45 minutes

  6. Time to Colonoscopy

    The time from when the patient started the bowel preparation to the colonoscopy procedure itself.

    Measured: From start of prep to time of procedure, up to 21 hours

  7. Hospital Length of Stay

    Time from admission to discharge

    Measured: After study completion, an average of 10 days

  8. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    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.

    Measured: Through study completion, an average of 3 days

  9. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1

    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?"

    Measured: Immediately prior to procedure

  10. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2

    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?"

    Measured: Immediately prior to procedure

  11. Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3

    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?"

    Measured: Immediately prior to procedure

  12. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1

    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"

    Measured: Immediately prior to procedure

  13. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2

    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"

    Measured: Immediately prior to procedure

  14. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3

    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"

    Measured: Immediately prior to procedure

  15. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4

    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"

    Measured: Immediately prior to procedure

  16. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5

    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"

    Measured: Immediately prior to procedure

  17. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6

    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"

    Measured: Immediately prior to procedure

  18. Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7

    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"

    Measured: Immediately prior to procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start12 Jan 2022
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054036
Sponsor's protocol ID
2000031169
Other IDs
000
Status last verified
Feb 2026
First submitted
9 Sep 2021
Last updated
11 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21.

    PubMed 26093612
  • Fuccio L, Frazzoni L, Spada C, Mussetto A, Fabbri C, Manno M, Aragona G, Zagari RM, Rondonotti E, Manes G, Occhipinti P, Cadoni S, Bazzoli F, Hassan C, Radaelli F; QIPS study group. Factors That Affect Adequacy of Colon Cleansing for Colonoscopy in Hospitalized Patients. Clin Gastroenterol Hepatol. 2021 Feb;19(2):339-348.e7. doi: 10.1016/j.cgh.2020.02.055. Epub 2020 Mar 18.

    PubMed 32200083
  • Spadaccini M, Frazzoni L, Vanella G, East J, Radaelli F, Spada C, Fuccio L, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Van Hooft JE, Dumonceau JM, Marmo C, Alfieri S, Chandrasekar VT, Sharma P, Rex DK, Repici A, Hassan C. Efficacy and Tolerability of High- vs Low-Volume Split-Dose Bowel Cleansing Regimens for Colonoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1454-1465.e14. doi: 10.1016/j.cgh.2019.10.044. Epub 2019 Nov 1.

    PubMed 31683057
  • Garber A, Sarvepalli S, Burke CA, Bhatt A, Ibrahim M, McMichael J, Morris-Stiff G, Rizk MK, Vargo JJ, Rothberg MB. Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med. 2019 May;14(5):278-283. doi: 10.12788/jhm.3173.

    PubMed 30986186
  • Patel M, Staggs E, Thomas CS, Lukens F, Wallace M, Almansa C. Development and validation of the Mayo Clinic Bowel Prep Tolerability Questionnaire. Dig Liver Dis. 2014 Sep;46(9):808-12. doi: 10.1016/j.dld.2014.05.020. Epub 2014 Jun 19.

    PubMed 24953203
  • Xiao K, Khan F, Link R, Dominguez-Diaz A, Ameyaw P, Alexis J, Tai CH, Assalone V, Nasufi M, Hughes ML, Loeser C, Hung K, Li DK. Efficacy and Safety of Low Volume Bowel Preparation for Colonoscopy in Hospitalized Patients: A Randomized Noninferiority Trial. J Clin Gastroenterol. 2025 Oct 24. doi: 10.1097/MCG.0000000000002269. Online ahead of print.

    PubMed 41128725

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MoviPrep and Golytely in people with Bowel Preparation Before Colonoscopy, run by Yale University at 2 sites in United States.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adequate Bowel Preparation (time frame: At time of procedure, approximately 45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054036, which also lists 6 linked publications.

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 11 Mar 2026.

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