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

NCT ID: NCT05284136

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2026-04-01

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Crohn's disease exclusion diet (CDED)

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

Group Type: EXPERIMENTAL

Crohn's disease exclusion diet (CDED)

Intervention Type: DIETARY_SUPPLEMENT

16-week course of CDED+Partial Enteral Nutrition. During the first 6 weeks (phase 1 of CDED), patients will be prescribed the CDED and oral Modulen 1 liter (1000kcal) daily. Between week 6 and 16 (phase 2 of CDED), patients will be prescribed CDED and oral Modulen (500 mL).

Steroids

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

Group Type: ACTIVE_COMPARATOR

Oral prednisolone

Intervention Type: DRUG

oral prednisolone at an initial dose of 40 to 60 mg/day (or 1 mg/kg for those patients who weigh less than 40 kg), with a fixed, tapering regimen such that patients should be off steroids by the last day of week 12. Increases in steroid dose during tapering of corticosteroids is allowed but if the patient receives steroids (other than hydrocortisone for adrenal insufficiency) after week 12, he/she is in failure.

Interventions

Crohn's disease exclusion diet (CDED)

16-week course of CDED+Partial Enteral Nutrition. During the first 6 weeks (phase 1 of CDED), patients will be prescribed the CDED and oral Modulen 1 liter (1000kcal) daily. Between week 6 and 16 (phase 2 of CDED), patients will be prescribed CDED and oral Modulen (500 mL).

Intervention Type: DIETARY_SUPPLEMENT

Oral prednisolone

oral prednisolone at an initial dose of 40 to 60 mg/day (or 1 mg/kg for those patients who weigh less than 40 kg), with a fixed, tapering regimen such that patients should be off steroids by the last day of week 12. Increases in steroid dose during tapering of corticosteroids is allowed but if the patient receives steroids (other than hydrocortisone for adrenal insufficiency) after week 12, he/she is in failure.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology department

Le Kremlin-Bicêtre, , France

Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC

Amsterdam, , Netherlands

Countries

France; Netherlands

Central Contacts

Franck Carbonnel, MD-PHD

Role: CONTACT

fcarbonnel7@gmail.com

142499742 ext. 33

matthieu Resche-Rigon, MD-PHD

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

142499747 ext. 33

Facility Contacts

Marloes Zwart, MD

Role: primary

m.zwart2@amsterdamumc.nl

20 5661242 ext. 31

Other Identifiers

APHP200030

Identifier Type: -

Identifier Source: org_study_id