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

NCT05054036 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2000031169000
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Bowel Preparation Before Colonoscopy

Keywords

colonoscopy; bowel preparation; inpatient; tolerability

Outcome Measures

Primary Outcomes (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.

  At time of procedure, approximately 45 minutes

Secondary Outcomes (18)

• Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment

  At time of procedure, approximately 45 minutes

• Number of Participants With "Excellent" Bowel Preparation

  At time of procedure, approximately 45 minutes

• Cecal Intubation

  At time of procedure, approximately 45 minutes

• Cecal Intubation Time

  At time of procedure, approximately 45 minutes

• Colonoscopy Withdrawal Time

  At time of procedure, approximately 45 minutes

Study Arms (2)

MoviPrep

EXPERIMENTAL

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

GoLYTELY

ACTIVE COMPARATOR

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

Interventions

MoviPrep DRUG

Split-dose MoviPrep bowel preparation

MoviPrep

Golytely DRUG

Split-dose GoLYTELY bowel preparation

GoLYTELY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known hypersensitivity to polyethylene glycols or ascorbic acid
• Patients undergoing colonoscopy for foreign body removal and/or decompression
• Pregnancy or lactating women

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale New-Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (6)

• 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.

  PMID: 26093612 BACKGROUND

• 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.

  PMID: 32200083 BACKGROUND

• 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.

  PMID: 31683057 BACKGROUND

• 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.

  PMID: 30986186 BACKGROUND

• 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.

  PMID: 24953203 BACKGROUND

• 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.

  PMID: 41128725 DERIVED

MeSH Terms

Interventions

MoviPrep; Golytely

Results Point of Contact

• Title: Darrick Li
• Organization: Yale School of Medicine

darrick.li@yale.edu

(203) 785-7312

Study Officials

• Darrick K Li, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 23, 2021
• Study Start: January 12, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)