Crohn DiseasePhase 2/3PARADISENCT05284136
Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease
A Phase 2/3 study testing Crohn's disease exclusion diet (CDED) and Oral prednisolone in people with Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Crohn's disease exclusion diet (CDED) and Oral prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2022to 1 Apr 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Department of Gastroenterology & Hepatology (MDL), Amsterdam UMC
Amsterdam, 1105 AZ
Marloes Zwart, MD, 20 5661242 ext. 31, m.zwart2@amsterdamumc.nl
Marjolijn Duijvestein, MD
About this study
Official title: Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE
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
- Being tested
- Crohn's disease exclusion diet (CDED), Oral prednisolone
- Keywords
- Crohn Disease, Diet, Corticosteroids
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Oral prednisoloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease exclusion diet (CDED) | Experimental | 16-week course of Crohn's disease exclusion diet (CDED) and Partial Enteral Nutrition. Receives: Dietary Supplement: Crohn's disease exclusion diet (CDED) |
| Steroids | Active comparator | oral prednisolone at an initial dose of 40 to 60 mg/day. Receives: Drug: Oral prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (13)
Rate of Clinical remission
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.
Measured: Week 16 and Week 48
Rate of Clinical response
Decrease of at least 70 points in Crohn's disease activity index (CDAI) compare to CDAI baseline.
Measured: Week 16 and Week 48
Rate of Need for further therapeutic intervention
Need for further therapeutic intervention (i.e., steroids, immunosuppressants, new biologic or surgery) between week 13 and 48
Measured: Week 48
Decrease of fecal calprotectin concentration
Decrease of fecal calprotectin of at least 50% compared to baseline at week 16 and 48
Measured: Week 16 and Week 48
Rate of Fecal calprotectin below thresholds
Fecal calprotectin of less than 250 μg/g, less than 100 μg/g and less than 50 μg/g at week 16.
Measured: Week 16
Rate of normal CRP concentration
CRP serum level <5 mg/L.
Measured: Week 16 and Week 48
Rate of Endoscopic remission
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.
Measured: Week 16
Rate of Endoscopic response
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.
Measured: Week 16
Gut microbiota composition
Gut microbiota composition at week 6 and week 16. The endpoint consist in the rate of the diffrent microorganisms present in the gut.
Measured: Week 6 and Week 16
Value of adherence by Medication Adherence Report Scale
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.
Measured: Week 1, Week 9 and Week 16
Rate of adherence using food diaries
Adherence evaluate as binuary outcome evaluated using food diaries at week 1, 9 and 16
Measured: Week 1, Week 9 and Week 16
Value of Quality of life
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).
Measured: Week 3, Week 6 and Week 16
Value Work
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.
Measured: Week 6 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284136
- Sponsor's protocol ID
- APHP200030
- Acronym
- PARADISE
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE
- ClinicalTrials.gov ID
- NCT05284136
- Acronym / sponsor ID
- PARADISE / APHP200030
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Diet, Corticosteroids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease exclusion diet (CDED) | Experimental | Dietary Supplement: Crohn's disease exclusion diet (CDED)16-week course of Crohn's disease exclusion diet (CDED) and Partial Enteral Nutrition. |
| Steroids | Active comparator | Drug: Oral prednisoloneoral prednisolone at an initial dose of 40 to 60 mg/day. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | Crohn's disease exclusion diet (CDED) |
| Oral prednisoloneoral 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. | Drug | Steroids |
Primary outcome
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.
13 secondary outcomes
Rate of Clinical remission
Time frame: Week 16 and Week 48
Rate of Clinical response
Time frame: Week 16 and Week 48
Rate of Need for further therapeutic intervention
Time frame: Week 48
Decrease of fecal calprotectin concentration
Time frame: Week 16 and Week 48
Rate of Fecal calprotectin below thresholds
Time frame: Week 16
Rate of normal CRP concentration
Time frame: Week 16 and Week 48
Rate of Endoscopic remission
Time frame: Week 16
Rate of Endoscopic response
Time frame: Week 16
Gut microbiota composition
Time frame: Week 6 and Week 16
Value of adherence by Medication Adherence Report Scale
Time frame: Week 1, Week 9 and Week 16
Rate of adherence using food diaries
Time frame: Week 1, Week 9 and Week 16
Value of Quality of life
Time frame: Week 3, Week 6 and Week 16
Value Work
Time frame: Week 6 and Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Crohn's disease exclusion diet (CDED) and Oral prednisolone in people with Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franck Carbonnel, MD-PHD (142499742 ext. 33, fcarbonnel7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic response W16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.