Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patien… (NCT05117996) | Clinical Trial Compass
CompletedNot Applicable
Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease
France144 participantsStarted 2022-07-05
Plain-language summary
The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease.
In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.
In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.
Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both genders aged over 18 years old
* With an established diagnosis of Crohn's disease, whether active or quiescent
* With an indication of a small bowel capsule endoscopy
* Without any small bowel stricture (patency capsule procedure on the 7 days before the capsule endoscopy)
* Registered with a social security scheme
* Having provided their oral consent for the study after appropriate information
Exclusion Criteria:
* \- Patients aged below 18 years old
* Diagnosis of ulcerative colitis or IBD unclassified
* Presence of an ileostomy
* Presence of a small bowel syndrome
* Symptoms suggestive of a small bowel stricture
* Retention of the patency capsule on an abdominal X-ray performed 48 hours after the ingestion
* Abdominal pain after the ingestion of the patency capsule
* Planned abdominal surgery in the next month
* Known intestinal fistula
* Swallowing disorders
* Established diagnosis of delayed gastric emptying or suggestive symptoms
* Intake of non-steroidal anti-inflammatory drugs (NSAIDs) in the month prior to the capsule endoscopy
* Intake of oral iron supplementation in the week prior to the capsule endoscopy
* Intake of oral 5-ASA granules in the week prior to the capsule endoscopy
* Ongoing pregnancy
* Presence of a pace-maker or implantable defibrillator
* Known allergy to polyethylene glycol or to lactose
* Vulnerable people i.e. adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
KODA score (entire small bowel)
Timeframe: through the reading of the capsule endoscopy, an average of 6 months