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

NCT05284136 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: APHP200030
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

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

Keywords

Crohn Disease; Diet; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• Endoscopic response W16

  The primary endpoint is the endoscopic response at week 16, assessed by Panenteric capsule (PillCam Crohn's capsule) using centralized, anonymous and blinded reading of PCC. The response is defined as a single binary endpoint according to the initial strata of the patient: * Small bowel Crohn's diseAse (CD) : decrease of the Lewis score of at least 50% compared to baseline values * Colonic CD : decrease of SES-CD of at least 50% compared to baseline values * Small bowel and colonic CD : decrease of the Lewis score of at least 50% AND decrease of SES-CD of at least 50% compared to baseline values. Lewis score : Gralnek IM, Defranchis R, et al. Development of a capsule endoscopy scoring index for small bowel mucosal inflammatory change. Aliment Pharmacol Ther 2008; 27: 146-154. SES-CD : Daperno M, D'Haens G, et al . Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc 2004; 60 (4): 505-512.

  Week 16

Secondary Outcomes (13)

• Rate of Clinical remission

  Week 16 and Week 48

• Rate of Clinical response

  Week 16 and Week 48

• Rate of Need for further therapeutic intervention

  Week 48

• Decrease of fecal calprotectin concentration

  Week 16 and Week 48

• Rate of Fecal calprotectin below thresholds

  Week 16

Study Arms (2)

Crohn's disease exclusion diet (CDED)

EXPERIMENTAL

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

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

Steroids

ACTIVE COMPARATOR

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

Drug: Oral prednisolone

Interventions

Crohn's disease exclusion diet (CDED) 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).

Crohn's disease exclusion diet (CDED)

Oral prednisolone 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.

Steroids

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Gastroenterology department

Le Kremlin-Bicêtre, 94, France

Location

Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Franck Carbonnel, MD-PHD

CONTACT

142499742; fcarbonnel7@gmail.com

matthieu Resche-Rigon, MD-PHD

CONTACT

142499747; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 17, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 17, 2022

Record last verified: 2022-02

Locations

FR (1); NL (1)