Differences in Preparation for Small Bowel Capsule Endoscopy

NCT03351972 | Completed Phase 4 DMC

• 1 other identifier: STH20061
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Clinician assessed Visual Quality of small bowel

  Visual quality of the small bowel during capsule endoscopy as assessed by a clinician

  1 day

• clinician assessed Diagnostic yield during capsule endoscopy

  Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician

  1 day

Study Arms (3)

Bowel Prep routine

ACTIVE COMPARATOR

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

Drug: Klean Prep

Bowel Prep Split

ACTIVE COMPARATOR

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

Drug: Klean Prep

No bowel prep

EXPERIMENTAL

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

Other: Clear liquids only

Interventions

Klean Prep DRUG

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

Also known as: Polyethylene Glycol

Bowel Prep Split; Bowel Prep routine

Clear liquids only OTHER

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

No bowel prep

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Hotel Dieu Hospital: collaborator

Study Sites (2)

Hotel Dieu Hospital

Kingston, Ontario, Canada

Location

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Celiac Disease

Interventions

klean prep; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mark McAlindon, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 24, 2017
• Study Start: November 23, 2017
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (1)