Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease

NCT05117996 | Completed

• 1 other identifier: RC21_0123
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• KODA score for each small bowel segment

  through the reading of the capsule endoscopy, an average of 6 months

• Qualitative assessment by the reader

  through the reading of the capsule endoscopy, an average of 6 months

• Quantitative assessment of acceptability of preparation

  Immediately before the capsule endoscopy

• Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent)

  Immediately before the capsule endoscopy

• Lewis score

  through the reading of the capsule endoscopy, an average of 6 months

Study Arms (2)

Standard small bowel preparation

ACTIVE COMPARATOR

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; Other: standard small bowel preparation

Simplified small bowel preparation

EXPERIMENTAL

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; Other: Simplified small bowel preparation

Interventions

capsule endoscopy OTHER

capsule endoscopy

Simplified small bowel preparation; Standard small bowel preparation

standard small bowel preparation OTHER

2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule

Standard small bowel preparation

Simplified small bowel preparation OTHER

Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule

Simplified small bowel preparation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

Angers University Hospital

Angers, France

Location

Vendée departmental hospital

La Roche-sur-Yon, France

Location

Clinique Jules Verne

Nantes, France

Location

Hopital privé Confluent

Nantes, France

Location

Nantes University Hospital

Nantes, France

Location

Rennes University hospital

Rennes, France

Location

Related Publications (1)

• Rouveyre R, Coudol S, Collins M, de Maissin A, Flamant M, Trang C, Freyssinet M, Bouguen G, Dib N, Bourreille A, Le Berre C. Clinical Trial: Simplified Bowel Preparation for Small Bowel Capsule Endoscopy in Crohn's Disease. Aliment Pharmacol Ther. 2026 Jan;63(1):57-69. doi: 10.1111/apt.70417. Epub 2025 Oct 20.

  PMID: 41116605 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 11, 2021
• Study Start: July 5, 2022
• Primary Completion: March 13, 2024
• Study Completion: April 22, 2024
• Last Updated: August 26, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)