Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease (PARADISE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Crohn Disease

Treatments: Dietary Supplement: Crohn's disease exclusion diet (CDED); Drug: Oral prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05284136

APHP200030

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Crohn's disease exclusion diet (CDED)

Experimental group

Description:

16-week course of Crohn's disease exclusion diet (CDED) and Partial Enteral Nutrition.

Treatment:

Dietary Supplement: Crohn's disease exclusion diet (CDED)

Steroids

Active Comparator group

Description:

oral prednisolone at an initial dose of 40 to 60 mg/day.

Treatment:

Drug: Oral prednisolone