Official Title: “A Randomised Study of the Optimal Bowel Preparation for Routine Capsule Endoscopy Using Citramag and Senna or Metoclopramide”

The aim of this study is to determine whether taking bowel preparation (citramag and senna) or a medicine to speed up transit through the stomach (metoclopramide), will improve the quality of the images seen, increase the transit through the small bowel, and increase the rate of completion of capsule endoscopy. The secondary objective is to determine whether patients could routinely tolerate this bowel preparation prior to capsule endoscopy and whether the diagnostic yield of capsule endoscopy is improved.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Capsule endoscopy is a diagnostic tool for the detection of small bowel disease allowing noninvasive endoscopic examination of the entire small bowel without the need for sedation.

Its limited battery life of 8+/-1 hours means it is paramount that the Capsule reaches the caecum, visualizing the whole of the small intestine, and also that the mucosal views obtained are clear, facilitating detection of pathologic lesions.

So far no optimal protocol for bowel preparation prior to Capsule endoscopy has been established. Recently, several studies have shown that bowel preparation with polyethylene glycol significantly reduces both gastric and small bowel transit times. Similarly, visualization of the small intestine and therefore 'diagnostic yield' have both been shown to be improved by both sodium phosphate and polyethylene glycol preparation. A more recent study by Selby et al also demonstrates that the prokinetic agent metoclopramide (which is known to promote emptying of the stomach) reduced both stomach and small bowel transit time, increasing completion rates from 76% to 97%). The proposal is to perform a randomised, controlled study using Citramag and Senna bowel preparation or Metoclopramide to determine whether test completion rates are improved and whether the images of the bowel are of better quality.

The hypothesis is that the improved wall visibility and increased completion rates will improve the diagnostic yield of Capsule endoscopy and therefore improve patient care.

Intervention(s) in this Clinical Trial

• Drug: Senna
• Drug: Citramag powder
• Drug: Metoclopramide

Primary Measures

• Quality of capsule endoscopic images, stomach and small bowel transit times and capsule completion rates to the end of the small bowel

Secondary Measures

• The tolerance of the bowel preparation to indicate future usage

Inclusion Criteria:

• Patients over 18 who have been referred for capsule endoscopy

Exclusion Criteria:

• Under 18
• Known or suspected gastrointestinal tract obstruction as this may impede passage of the capsule
• Known small bowel stricture or fistula as this may impede capsule passage
• Pregnancy, breast feeding or phaeochromocytoma as metoclopramide is contraindicated
• Recent gastrointestinal surgery in view of the risk of impeded capsule passage
• Permanent cardiac pacemaker or implantable defibrillator in-situ to avoid the risk of possible interference
• Congestive cardiac failure as citramag is contraindicated in such patients

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North West London Hospitals NHS Trust

Overall Clinical Trial Officials and Contacts

Christopher Fraser, MB BCH, MD, FRCP Principal Investigator St Mark's Hospital, North West London Hospitals NHS Trust  

Overall Contact: Christopher Fraser, MB BCH, MD, FRCP  chris.fraser@imperial.ac.uk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00275184

Study ID Number: 05/CE/94

ClinicalTrials.gov Identifier: NCT00275184

Health Authority: United Kingdom: National Health Service

North West London Hospitals NHS Trust web includes links to St Mark's