Informations générales (source: ClinicalTrials.gov)
Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE (PARADISE)
Interventional
Phase 2/Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2022
avril 2026
19 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | AMIOT Aurelien | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | AMIOT Aurelien | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | AMIOT Aurelien | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Robert Debré | AMIOT Aurelien | 18/04/2025 07:55:26 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | AMIOT Aurelien | 18/04/2025 07:55:26 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Gastroenterology department - 94 - Le Kremlin Bicetre - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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)