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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 70 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05284136
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France, Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Experimental: Crohn's disease exclusion diet (CDED)

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

Active Comparator: Steroids

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

Interventions

Dietary Supplement: - 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).

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gastroenterology department, Le Kremlin Bicetre, France

Status

Address

Gastroenterology department

Le Kremlin Bicetre, , 94

Amsterdam, Netherlands

Status

Address

Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC

Amsterdam, , 1105 AZ

Site Contact

Marloes Zwart, MD

m.zwart2@amsterdamumc.nl

20 5661242 #31