Prospective rAndomized controlled tRial of Crohn*s diseAse exclusion Diet vs corticosteroIds in patientS with activE Crohn*s disease

Recruiting

• Conditions: Crohn's disease; Inflamatory Bowel Disease; 10017966

• Registration Number: NL-OMON53395
• Lead Sponsor: Assistance Publique-Hopitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Patients aged 16 to 70 years,
- With mild to moderate, luminal, active CD, defined by a HBI of 5 to 16,
involving the small bowel, and/or the colon
- Not treated with corticosteroids at baseline
- Patients either naïve or previously exposed to a maximum of two classes of
biologics or currently receiving a biologic therapy, and exposed to a maximum
of two classes of biologic therapy, including the current one
- Patent small bowel as assessed by the patency capsule
- Active endoscopic lesions, as defined by Lewis score >= 225 in the small bowel
and/or SES-CD>= 4 in the colon. The eligibility of the patient will be
determined by the site investigator and a central reader.

Exclusion Criteria

- Inability to follow the CDED during 16 weeks.
- Prior intolerance to corticosteroids.
- Ongoing infections, evolving virus diseases.
- Live vaccines.
- Arthritis or uveitis as main presenting symptoms.
- Patients with severe and/or predominant rectal or perianal disease.
- Heavy smokers (more than 10 cigarettes per day).
- Infliximab, adalimumab, methotrexate or azathioprine initiated less than 3
months before inclusion in this trial.
- Vedolizumab, ustekinumab initiated less than 6 months before inclusion in
this trial.
- Change in methotrexate, azathioprine, infliximab, adalimumab, vedolizumab or
ustekinumab dosage less than 3 months before inclusion.
- Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: endoscopic response at week 16, without corticosteroids or<br /><br>further therapeutic intervention, assessed by a centralized, anonymous and<br /><br>blinded, double lecture panel of panenteric PillCam Crohn*s Capsule (PCC).<br /><br>Endoscopic response is defined by a decrease of at least 50% in the Lewis score<br /><br>for patients with small bowel CD, decrease of SES-CD of at least 50% in<br /><br>patients with colonic CD and both of these in patients with small bowel and<br /><br>colonic CD, compared to baseline</p><br>