NCT05117996Completed
Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease
Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study
Source: ClinicalTrials.gov · Last updated 26 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 21 Oct 2021
- Start date
- 5 Jul 2022
- Primary completion date
- 13 Mar 2024
- Lead sponsor
- Nantes University Hospital
- Diseases
- Crohn's disease
- NCT number
- NCT05117996
What you commit to
- Study type: Interventional
- Participants enrolled: 144
- From 5 Jul 2022 to the primary completion date, 13 Mar 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned abdominal surgery in the next month
- 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
Other illness
- Presence of a small bowel syndrome
- Known intestinal fistula
- Swallowing disorders
- Known allergy to polyethylene glycol or to lactose
Age
- \- Patients aged below 18 years old
Other
- Diagnosis of ulcerative colitis or IBD unclassified
- Presence of an ileostomy
- 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
- Established diagnosis of delayed gastric emptying or suggestive symptoms
- Ongoing pregnancy
- Presence of a pace-maker or implantable defibrillator
- Vulnerable people i.e. adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Angers University Hospital Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Vendée Departmental Hospital Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Clinique Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Nantes University Hospital Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hopital Prive Confluent Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Rennes University Hospital Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.