Status:
NOT_YET_RECRUITING
Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Crohn Disease
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05284136
Start Date
April 1 2022
End Date
April 1 2026
Last Update
March 17 2022
Active Locations (2)
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1
Gastroenterology department
Le Kremlin-Bicêtre, France, 94
2
Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC
Amsterdam, Netherlands, 1105 AZ