Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease (PARADISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05284136|
Recruitment Status : Not yet recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Dietary Supplement: Crohn's disease exclusion diet (CDED) Drug: Oral prednisolone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE|
|Estimated Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||August 1, 2025|
|Estimated Study Completion Date :||April 1, 2026|
Experimental: Crohn's disease exclusion diet (CDED)
16-week course of Crohn's disease exclusion diet (CDED) and Partial Enteral Nutrition.
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).
Active Comparator: Steroids
oral prednisolone at an initial dose of 40 to 60 mg/day.
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.
- Endoscopic response W16 [ Time Frame: Week 16 ]
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.
- Rate of Clinical remission [ Time Frame: Week 16 and Week 48 ]
Crohn's disease activity index (CDAI) <150. CDAI will be measured by the investigator on the basis of prospective questionnaires filled in by patients during the week preceding each visit.
Best, William R., Jack M. Becktel, John W. Singleton, and Fred Kern Jr. "Development of a Crohn's disease activity index: National Cooperative Crohn's Disease Study." Gastroenterology 70, no. 3 (1976): 439-444.
- Rate of Clinical response [ Time Frame: Week 16 and Week 48 ]Decrease of at least 70 points in Crohn's disease activity index (CDAI) compare to CDAI baseline.
- Rate of Need for further therapeutic intervention [ Time Frame: Week 48 ]Need for further therapeutic intervention (i.e., steroids, immunosuppressants, new biologic or surgery) between week 13 and 48
- Decrease of fecal calprotectin concentration [ Time Frame: Week 16 and Week 48 ]Decrease of fecal calprotectin of at least 50% compared to baseline at week 16 and 48
- Rate of Fecal calprotectin below thresholds [ Time Frame: Week 16 ]Fecal calprotectin of less than 250 μg/g, less than 100 μg/g and less than 50 μg/g at week 16.
- Rate of normal CRP concentration [ Time Frame: Week 16 and Week 48 ]CRP serum level <5 mg/L.
- Rate of Endoscopic remission [ Time Frame: Week 16 ]
Endoscopic remission as defined as Lewis score <135 in the small bowel and/or Simple Endoscopic Score for Crohn Disease (SES-CD) <4 in the colon, without further therapeutic intervention (surgery, biologics or dietary intervention) at week 16.
Dias de Castro, F., Pedro Boal Carvalho, Sara Monteiro, Bruno Rosa, João Firmino-Machado, Maria João Moreira, and José Cotter. "Lewis score-prognostic value in patients with isolated small bowel Crohn's disease." Journal of Crohn's and Colitis 9, no. 12 (2015): 1146-1151.
Daperno, Marco, Geert D'Haens, Gert Van Assche, Filip Baert, Philippe Bulois, Vincent Maunoury, Raffaello Sostegni et al. "Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD." Gastrointestinal endoscopy 60, no. 4 (2004): 505-512.
- Rate of Endoscopic response [ Time Frame: Week 16 ]
Endoscopic response and remission graded by Eliakim score at week 16.
Eliakim, Rami, et al. "A novel PillCam Crohn's capsule score (Eliakim score) for quantification of mucosal inflammation in Crohn's disease." United European gastroenterology journal 8.5 (2020): 544-551.
- Gut microbiota composition [ Time Frame: Week 6 and Week 16 ]Gut microbiota composition at week 6 and week 16. The endpoint consist in the rate of the diffrent microorganisms present in the gut.
- Value of adherence by Medication Adherence Report Scale [ Time Frame: Week 1, Week 9 and Week 16 ]
Medication Adherence Report Scale (MARS) at week 1, 9 and 16.
Chan, Amy Hai Yan, Rob Horne, Matthew Hankins, and Claudia Chisari. "The medication adherence report scale: a measurement tool for eliciting patients' reports of nonadherence." British Journal of Clinical Pharmacology 86, no. 7 (2020): 1281-1288.
- Rate of adherence using food diaries [ Time Frame: Week 1, Week 9 and Week 16 ]Adherence evaluate as binuary outcome evaluated using food diaries at week 1, 9 and 16
- Value of Quality of life [ Time Frame: Week 3, Week 6 and Week 16 ]
Quality of life will be assessed by short inflammatory bowel disease questionnaire (IBDQ) at week 3, 6 and 16.
Irvine, E. J., Q. Zhou, and A. K. Thompson. "The Short Inflammatory Bowel Disease Questionnaire: A Quality of Life Instrument for Community Physicians Managing Inflammatory Bowel Disease." American Journal of Gastroenterology (Springer Nature) 91.8 (1996).
- Value Work [ Time Frame: Week 6 and Week 16 ]
Work productivity and activity will be assessed by thework productivity and activity impairment questionnaire (WPAI) at 6 and 16.
Reilly, Margaret C., Arthur S. Zbrozek, and Ellen M. Dukes. "The validity and reproducibility of a work productivity and activity impairment instrument." Pharmacoeconomics 4.5 (1993): 353-365.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05284136
|Contact: Franck Carbonnel, MD-PHD||142499742 ext firstname.lastname@example.org|
|Contact: matthieu Resche-Rigon, MD-PHD||142499747 ext email@example.com|
|Le Kremlin Bicetre, France, 94|
|Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Marloes Zwart, MD 20 5661242 ext 31 firstname.lastname@example.org|
|Principal Investigator: Marjolijn Duijvestein, MD|