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Phase 4

Polyethylene Glycol

Sponsor:

Sheffield Teaching Hospitals NHS Foundation Trust

Code:

NCT03351972

Conditions

Capsule Endoscopy

Inflammatory Bowel Diseases

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Klean Prep

Clear liquids only

Study Details

Brief summary:

The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia, inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the intestine, thus making it susceptible to decreased visualization quality and diagnostic yield due to dark intestinal contents or air bubbles. In order to determine the best method for bowel preparation before Capsule Endoscopy, this study seeks to determine in patients undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the aggregate of all the active preparation groups compared to than clear fluids only group. Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel examination by time) and small bowel transit time (measured as time from first duodenal image to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy will be considered for the study and this will run in the clinical environment as per routine. Patients will have been referred for capsule endoscopy as per normal clinical practice so not additional procedure will take place. Patients will be randomly assigned to in a one to one fashion to one of three groups in order to explore whether bowel preparation (either as a single or divided dose) produce better cleansing and diagnostic yield than no preparation at all in small bowel capsule endoscopy.

Conditions

Capsule Endoscopy

Inflammatory Bowel Diseases

Celiac Disease

Study ID

NCT03351972

Start date

Nov 23, 2017

Status verified date

Apr, 2026

Completion date

Mar 31, 2025

Primary completion date

Mar 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult outpatients (18 years or older)
  • routinely referred for small bowel video capsule endoscopy (CE)

Exclusion Criteria:

  • dysphagia
  • severe gastroparesis requiring endoscopic placement of capsule
  • small bowel obstruction
  • pregnancy

Study Design

Enrollment

230 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Bowel Prep routine

Participants randomised to this arm will receive their bowel prep (Klean Prep) with the routine guidance of taking the contents the day before their capsule endoscopy

active comparator: Bowel Prep Split

Participants randomised to this arm will receive their bowel prep (Klean Prep) with the guidance stating to take the first dose the day before the capsule endoscopy and the second dose the morning of the capsule endoscopy

experimental: No bowel prep

Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure

Interventions

Klean Prep

Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure

Clear liquids only

Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure

Primary outcome measure

  • Clinician assessed Visual Quality of small bowel [ Time Frame: 1 day ]
  • clinician assessed Diagnostic yield during capsule endoscopy [ Time Frame: 1 day ]

Central Contacts and Locations

More Information

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Sheffield Teaching Hospitals NHS Foundation Trust on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.