Clinical trial NCT05284136: Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease
Official title: Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Crohn Disease
Keywords: Crohn Disease
Diet
Corticosteroids
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crohn's disease exclusion diet (CDED) is a whole-food diet coupled with partial enteral nutrition. The main objective of this trial is to assess whether CDED is superior to corticosteroids, in terms of endoscopic response, in patients active CD. The primary endpoint is endoscopic response at week 16, without corticosteroids or further therapeutic intervention, assessed by a centralized, anonymous and blinded, double lecture panel of panenteric PillCam Crohn's Capsule. This is a multicentre, open-label, comparative, randomized, 2:1, controlled, single-blind, superiority trial. Patients included are aged 16 to 70 years, have mild to moderate, luminal, active CD, and have active endoscopic lesions. Eighty patients will be randomized between CDED (n=56) and corticosteroids (n=24) in centres in France, Israel and the Netherlands.


Eligibility criteria: Inclusion Criteria:

* Patients aged 16 to 70 years,
* With mild to moderate, luminal, active CD, defined by a CDAI of 150 to 350,
* Involving the small bowel, and/or the colon
* Not treated with corticosteroids at baseline
* 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.
* Informed consent to participate in this study. In patients from France and Israel who are aged less than 18: parents' informed consent to participate in this study (parents' agreement is not required in patients aged 16 to 18 in the Netherlands)
* Affiliation to social security or any health insurance

Exclusion Criteria:

* Inability to follow the CDED during 16 weeks.
* Prior intolerance to corticosteroids.
* Ongoing infections, evolving virus diseases.
* Live vaccines.
* Psychotic state not controlled by treatment.
* 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.
* Patients already included in a biomedical research other than an observational study (e.g. registry, cohort, biobank).
* Severe pubertal delay (Tanner 1 or Tanner 2) and/or height velocity z-score \< 2.5 and/or Bone mineral density z-score (hip or lumbar spine) \<2.5.
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)

Primary outcomes:
measure: Endoscopic response W16
timeFrame: Week 16
Secondary outcomes:
measure: Rate of Clinical remission
timeFrame: Week 16 and Week 48
measure: Rate of Clinical response
timeFrame: Week 16 and Week 48
measure: Rate of Need for further therapeutic intervention
timeFrame: Week 48
measure: Decrease of fecal calprotectin concentration
timeFrame: Week 16 and Week 48
measure: Rate of Fecal calprotectin below thresholds
timeFrame: Week 16
measure: Rate of normal CRP concentration
timeFrame: Week 16 and Week 48
measure: Rate of Endoscopic remission
timeFrame: Week 16
measure: Rate of Endoscopic response
timeFrame: Week 16
measure: Gut microbiota composition
timeFrame: Week 6 and Week 16
measure: Value of adherence by Medication Adherence Report Scale
timeFrame: Week 1, Week 9 and Week 16
measure: Rate of adherence using food diaries
timeFrame: Week 1, Week 9 and Week 16
measure: Value of Quality of life
timeFrame: Week 3, Week 6 and Week 16
measure: Value Work
timeFrame: Week 6 and Week 16
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: Gastroenterology department
city: Amsterdam
country: Netherlands
facility: Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC
Study officials:
References: