Crohn DiseaseCROHN-PREPNCT05117996
Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease
A study testing capsule endoscopy, standard small bowel preparation and Simplified small bowel preparation in people with Crohn Disease, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- capsule endoscopy, standard small bowel preparation and Simplified small bowel preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Jul 2022to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 18Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers
Vendée departmental hospital
La Roche-sur-Yon
Clinique Jules Verne
Nantes
Hopital privé Confluent
Nantes
Nantes University Hospital
Nantes
Rennes University hospital
Rennes
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- capsule endoscopy, standard small bowel preparation, Simplified small bowel preparation
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyOther
capsule endoscopy
standard small bowel preparationOther
2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
Simplified small bowel preparationOther
Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: capsule endoscopy; Other: Simplified small bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
KODA score (entire small bowel)
Small bowel preparation quality (entire small bowel)
Measured: through the reading of the capsule endoscopy, an average of 6 months
Secondary outcomes (7)
KODA score for each small bowel segment
Small bowel preparation quality (by segment : upper/middle/lower third)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Immediately before the capsule endoscopy
Lewis score
Diagnostic yield evaluation
Measured: 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
Measured: 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
Measured: through the reading of the capsule endoscopy, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start5 Jul 2022
- Primary completion13 Mar 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117996
- Sponsor's protocol ID
- RC21_0123
- Acronym
- CROHN-PREP
- Status last verified
- Apr 2024
- First submitted
- 21 Oct 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41116605
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05117996
- Acronym / sponsor ID
- CROHN-PREP / RC21_0123
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard small bowel preparation | Active comparator | Other: capsule endoscopy, Other: standard small bowel preparation2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule |
| Simplified small bowel preparation | Experimental | Other: capsule endoscopy, Other: Simplified small bowel preparationLiquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capsule endoscopycapsule endoscopy | Other | Simplified small bowel preparation, Standard small bowel preparation |
| standard small bowel preparation2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule | Other | Standard small bowel preparation |
| Simplified small bowel preparationLiquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule | Other | Simplified small bowel preparation |
Primary outcome
KODA score (entire small bowel)
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Small bowel preparation quality (entire small bowel)
7 secondary outcomes
KODA score for each small bowel segment
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Qualitative assessment by the reader
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Quantitative assessment of acceptability of preparation
Time frame: Immediately before the capsule endoscopy
Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent)
Time frame: Immediately before the capsule endoscopy
Lewis score
Time frame: through the reading of the capsule endoscopy, an average of 6 months
complete examinations
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Small bowel transit time
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 41116605Rouveyre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsule endoscopy, standard small bowel preparation and Simplified small bowel preparation in people with Crohn Disease, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KODA score (entire small bowel) (time frame: through the reading of the capsule endoscopy, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.