Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease (CROHN-PREP)

Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Other: capsule endoscopy; Other: standard small bowel preparation; Other: Simplified small bowel preparation

Detailed Description

Crohn's disease is a chronic inflammatory bowel disease characterized by the presence of ulcers that can affect the entire digestive tract, from the mouth to the anus. The existence of small bowel lesions is pejorative and associated with poorer outcomes and a higher risk of intestinal resection.

Small bowel capsule endoscopy allows the visualization of the entire small bowel in a non-invasive and outpatient setting, without any anesthesia. It is the exam with the best diagnostic yield for the detection of small bowel ulcers in patients with Crohn's disease. Moreover, it allows the monitoring of patients after initiating treatment to assess mucosal healing and the detection of post-operative recurrence.

As for any endoscopic examinations, its acceptability depends on bowel preparation modalities. The European Society of Gastrointestinal Endoscopy (ESGE) currently recommends to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, patients with Crohn's disease were a minority (< 1.5 %) in the studies on which these guidelines are based on.

Yet, in patients with small bowel Crohn's disease, polyethylene glycol may remove some fibrin from the ulcers and hence, 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.

A preliminary retrospective study 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 CROHN-PREP 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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Angers University Hospital
  • La Roche-sur-Yon, France
    • Vendée Departmental Hospital
  • Nantes, France
    • Nantes University Hospital
  • Nantes, France
    • Clinique Jules Verne
  • Nantes, France
    • Hopital Prive Confluent
  • Rennes, France
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard small bowel preparation; 2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule	Other: capsule endoscopy; capsule endoscopy; Other: standard small bowel preparation; 2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
Experimental: Simplified small bowel preparation; Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule	Other: capsule endoscopy; capsule endoscopy; Other: Simplified small bowel preparation; Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KODA score (entire small bowel)	Small bowel preparation quality (entire small bowel)	through the reading of the capsule endoscopy, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KODA score for each small bowel segment	Small bowel preparation quality (by segment : upper/middle/lower third)	through the reading of the capsule endoscopy, an average of 6 months
Qualitative assessment by the reader	Proportion of images in which preparation is considered as "good", "moderate" or "low" by the reader (by segment)	through the reading of the capsule endoscopy, an average of 6 months
Quantitative assessment of acceptability of preparation	Patient's acceptability of the bowel preparation on a visual analog scale between 0 (nil) to 10 (excellent)	Immediately before the capsule endoscopy
Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent)	Patient's acceptability of the examination on a visual analog scale between 0 (nil) to 10 (excellent)	Immediately before the capsule endoscopy
Lewis score	Diagnostic yield evaluation	through the reading of the capsule endoscopy, an average of 6 months
complete examinations	Percentage of complete examinations defined by the visualization of the first duodenal image and the first caecal image	through the reading of the capsule endoscopy, an average of 6 months
Small bowel transit time	Recording time between the visualization of the first duodenal image and the first caecal image, if visualized	through the reading of the capsule endoscopy, an average of 6 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: RC21_0123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No