The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation

NCT04361656 | Withdrawn DMC FDA Drug

• 1 other identifier: 1474341
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter interrupted-time series study. The study will include patients between the age of 18-85 year old, both males and females, who are scheduled for inpatient colonoscopy procedure. The study will be divided into two phases: The initial phase will be a prospective review of inpatient colonoscopy procedure between September, 1st 2020 and March, 31st 2021 to assess overall adequacy of inpatient colonoscopy preparation and patient satisfaction at the three participating sites using standard of care colonoscopy preparation prior to implement our intervention. The intervention phase will take place between April, 1st 2021 and October 31st 2021, where all patient undergoing inpatient colonoscopy procedures will receive Lubiprostone in addition to large-volume PEG-ELS. The patients will be evaluated with colonoscopy the next day. The preparation quality will be documented using the Boston Bowel Preparation Scale (BBPS).

Conditions

Colonoscopy Preparation

Outcome Measures

Primary Outcomes (2)

• Independent gastroenterologists BBPS review

  The Boston Bowel Preparation Scale (BBPS) is a four-point scoring system (0-3) applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum). Scores can range from 0-9.

  scored at completion of all data collection,or after 2023

• Participant satisfaction through standardized questionnaire form

  Adverse symptoms following colonoscopy can range from none (0) to severe (4)

  3 years

Secondary Outcomes (2)

• Colonoscopy procedure BBPS by performing gastroenterologist

  3 years

• Adverse event reporting

  3 years

Study Arms (2)

Current standard of care preparation

Current Standard of Care for inpatient colonoscopy: The dose of PEG-ELS will be large-volume (4-Liter) administered as either single-dose if colonoscopy is scheduled BEFORE 11 a.m. (250 mL orally every 15 minutes between 6 p.m. and midnight the day prior to procedure), or split-dose if the colonoscopy is scheduled AT or AFTER 11 a.m. (First dose: 2-Liters; 250 mL orally every 15 minutes between 6-8 p.m. the day prior to procedure. Second dose: 2-Liters; 250 mL orally every 15 minutes to be completed 5 hours before the scheduled time of the procedure).

Drug: PEG-ELS current standard of care

Lubiprostone Intervention

The study entails giving two doses of Lubiprostone in addition to the standard large-volume polythene glycol-electrolytes solution (PEG-ELS) according to the time of the procedure as follow: If the colonoscopy is scheduled BEFORE 11a.m. the patient will receive in addition to the PEG-ELS: Lubiprostone 24 mcg capsule orally (roughly every 12 hours) for total of 2 doses, with the last dose being at least 4 hours prior to the scheduled colonoscopy. If the colonoscopy is scheduled AT or AFTER 11a.m. the patient will receive in addition to PEG-ELS: Lubiprostone 24 mcg capsule orally 2 hours before each dose of the PEG-ELS

Drug: PEG-ELS current standard of care plus Lubiprostone 24 microgram Oral Cap (x2)

Interventions

PEG-ELS current standard of care DRUG

Standard of care for inpatient colonoscopy

Current standard of care preparation

PEG-ELS current standard of care plus Lubiprostone 24 microgram Oral Cap (x2) DRUG

The dose of Lubiprostone will be 24 mcg capsule orally (roughly every 12 hours) for total of 2 doses, with the last dose being at least 4 hours prior to the scheduled colonoscopy if it is BEFORE 11 a.m., and Lubiprostone 24 mcg capsule orally 2 hours before each dose of the PEG-ELS if colonoscopy is scheduled AT or AFTER 11 a.m..

Lubiprostone Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients having colonoscopy performed

You may qualify if:

• Is scheduled for colonoscopy evaluation during his hospitalization to one of the trial sites (SJPH, PPH, or SJMH).
• Has a negative urine pregnancy test (hCG) for female of reproductive age.
• Provide an Informed Consent / has a legally acceptable representative capable of understanding the Informed Consent document and providing consent on the participant's behalf.
• Provide a separate signed and dated Informed Consents for colonoscopy procedure and anaesthesia administration as per site policy.

You may not qualify if:

• Has a documented or suspected bowel obstruction (small bowel obstruction, volvulus, gastric outlet obstruction, ileus, or toxic megacolon).
• Has a documented gastroparesis.
• Has severe diarrhea (\>8 bowel movements per day).
• Has severe encephalopathy or obtunded (GCS \< 13).
• Has a documented or suspected acute coronary syndrome or recent myocardial infarction within 12 weeks prior to enrollment.
• Has renal impairment with GFR less than 30 ml/min/1.73 m2 on the day of enrollment (end-stage renal disease on renal replacement therapy can be enrolled).
• Has severe liver impairment with Child-Pugh class B or C.
• Has symptomatic heart failure (NYHA class III or IV) or prohibitive pre-procedure cardiac risk (documented by primary team or cardiology prior to enrollment).
• Has a known hypersensitivity to Lubiprostone or its class.
• Is pregnant or lactating.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (3)

Ascension Providence Hopsital (Novi)

Novi, Michigan, 48374, United States

Location

Ascension Providence Hospital, Southfield Campus

Southfield, Michigan, 48075, United States

Location

Ascension Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Related Publications (1)

• Grigg E, Schubert MC, Hall J, Rahhal F, Raina D, Sridhar S, Chamberlain SM. Lubiprostone used with polyethylene glycol in diabetic patients enhances colonoscopy preparation quality. World J Gastrointest Endosc. 2010 Jul 16;2(7):263-7. doi: 10.4253/wjge.v2.i7.263.

  PMID: 21160617 BACKGROUND

Study Officials

• Ali Zakaria, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: December 19, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)