Differences in Preparation for Small Bowel Capsule Endoscopy
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ClinicalTrials.gov Identifier: NCT03351972 |
Recruitment Status : Unknown
Verified October 2020 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : November 24, 2017
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Capsule Endoscopy Inflammatory Bowel Diseases Celiac Disease | Drug: Klean Prep Other: Clear liquids only | Phase 4 |
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).
Group Assignment:
The groups will have some common instructions: all groups will be instructed to stop iron supplements five days prior to the exam. On the day prior to the exam, patients will be instructed to have a light breakfast and lunch, followed by only clear fluids. Over the day, patients will be encouraged to have at least two litres of clear fluids. On the day of the exam, 80 mg of oral simethicone will be given 10 minutes prior to the exam. The capsule will be ingested at 9:00am, after which fluids may be consumed 2 hours later, and solid food 4 hours later. Patients will be randomly assigned to in a one to one fashion to one of three groups using a central online randomization program. The groups for this project include:
A. Control: no additional instructions beyond those above will be given. B. Single dose Polyethylene Glycol: Patients will take 2 litre of Polyethylene Glycol at 6am the day of the exam.
C. Split dose Polyethylene Glycol: Patients will take 1 litre of Polyethylene Glycol at 7pm the evening prior to the exam and 1 litre at 6am the day of the exam.
Recruitment of patients will be performed from outpatient gastroenterology clinics at Sheffield Teaching Hospitals NHS Trust. After a request for Capsule Endoscopy from a referring physician, the patient will be contacted by telephone by one of the Capsule endoscopy nurse specialists (who are also involved in the study) as per normal practice. The study will be discussed, the procedure explained and a convenient date for the procedure will be agreed with the patient. The patient will be invited to meet with one of the research staff at a mutually agreed time in order to go through the study once more and provide written consent should they agree to participate. Should they wish to participate but would prefer to complete a postal consent form, this will be arranged. The procedure will be completed according to normal practice. Patients will be advised that they can withdraw from the study at any point and choose a preferred option for bowel preparation
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Other |
Official Title: | Does 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 |
Actual Study Start Date : | November 23, 2017 |
Estimated Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | December 1, 2021 |

Arm | Intervention/treatment |
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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
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Drug: 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
Other Name: Polyethylene Glycol |
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
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Drug: 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
Other Name: Polyethylene Glycol |
Experimental: No bowel prep
Participants randomised to this arm will be advised to drink clear liquids only ahead of their capsule endoscopy procedure
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Other: Clear liquids only
Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure |
- Clinician assessed Visual Quality of small bowel [ Time Frame: 1 day ]Visual quality of the small bowel during capsule endoscopy as assessed by a clinician
- clinician assessed Diagnostic yield during capsule endoscopy [ Time Frame: 1 day ]Ability to produce a diagnosis following capsule endoscopy as assessed by a clinician

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351972
Contact: Mark McAlindon, MD | 0114 2711899 | Mark.McAlindon@sth.nhs.uk | |
Contact: Luke Barron, Mr | 0114 2711899 | Luke.Barron@sth.nhs.uk |
Canada, Ontario | |
Hotel Dieu Hospital | Recruiting |
Kingston,, Ontario, Canada | |
Contact: Laurence Hookey, MD hookeyl@hdh.kari.net | |
United Kingdom | |
Royal Hallamshire Hospital | Recruiting |
Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
Contact: Luke Barron, MSc 0114 2711899 luke.barron@sth.nhs.uk | |
Principal Investigator: Mark McAlindon, MD | |
Principal Investigator: Laurence Hookey, MD |
Principal Investigator: | Mark McAlindon, MD | Sheffield Teaching Hospitals NHS Foundation Trust |
Responsible Party: | Sheffield Teaching Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT03351972 |
Other Study ID Numbers: |
STH20061 |
First Posted: | November 24, 2017 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The study has been set-up and designed to ensure no IPD is shared |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammatory Bowel Diseases Celiac Disease Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Gastroenteritis Malabsorption Syndromes Metabolic Diseases |