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Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease (CD-HOPE)

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ClinicalTrials.gov Identifier: NCT02201693
Recruitment Status : Unknown
Verified April 2019 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
GETAID Pediatric
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE July 28, 2014
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE December 12, 2014
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
The first relapse [ Time Frame: 12 months ]
Assessed with wPCDAI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
  • Clinical remission [ Time Frame: 12 months ]
    Assessed with wPCDAI, CDAI, PGA
  • Time to the first relapse [ Time Frame: until month 12 ]
    Assessed with wPCDAI, CDAI, PGA
  • Variation of wPCDAI, [ Time Frame: until month12 ]
    Assessed with wPCDAI
  • Endoscopic remission [ Time Frame: month 12 ]
    CDEIS
  • Transmural healing [ Time Frame: Month 12 ]
    MRI
  • Calprotectin [ Time Frame: until month12 ]
    Fecal sample
  • Quality of life analysis [ Time Frame: Until Month 12 ]
    E-questionnaire
  • Growth pattern [ Time Frame: Until Month 12 ]
    Z-Score
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • Clinical remission [ Time Frame: 12 months ]
    Assessed with wPCDAI, CDAI, PGA
  • Time of the first relapse [ Time Frame: until month 12 ]
    Assessed with wPCDAI, CDAI, PGA
  • Variation of wPCDAI, [ Time Frame: until month12 ]
    Assessed with wPCDAI
  • Endoscopic remission [ Time Frame: month 12 ]
    CDGIS
  • Transmural healing [ Time Frame: Month 12 ]
    MRI
  • Calprotectin [ Time Frame: until month12 ]
    Fecal sample
  • Quality of life analysis [ Time Frame: Until Month 12 ]
    E-questionnaire
  • Growth pattern [ Time Frame: Until Month 12 ]
    Z-Score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Official Title  ICMJE Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Brief Summary The purpose of this study is to compare the rate of first relapse at 12 months between maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily calories) and maintenance therapy with supplementary enteral nutritional support (25% daily calories).
Detailed Description

Enteral nutrition (EN) is a highly efficacious treatment option for Crohn's disease (CD). In children, exclusive EN is considered first choice therapy to induce remission in pediatric CD, as highlighted in the recent ESPGHAN-ECCO guidelines. Several meta-analyses showed that the anti-inflammatory potential of EEN is comparable to the effects of steroids. In addition, children with CD often have marked growth retardation and EEN is one of the most efficacious treatment options to induce catch-up growth in these patients. There is convincing data indicating that EN is highly efficacious when given on an exclusive basis, while the use of partial EN is markedly less effective to induce remission in active Crohn's disease as compared to exclusive EN. Recently, it was suggested that exclusive EN has a dominant effect on the intestinal microbiota, which contributes to the induction of remission. There exists several strategies to maintain remission in children with CD, but there is no clear consensus on which maintenance treatment to follow. There are some indicators to believe that enteral nutritional therapy might play also a significant role as maintenance therapy for CD. Given the fact that many centers use a top-down approach with the introduction of immunosuppressors and/or biologics at/or shortly after diagnosis, the investigators wanted to test the possibility of a treatment option to efficiently maintain remission with less (or no) side effects based on enteral nutrition to avoid the early use of immunosuppressors.

It's a French multicenter, prospective, randomized study with PROBE (prospective randomized open blind end-point) evaluation. Randomization will be performed in a blinded and centralized manner, allocating patients to one of the two treatment groups :

  • ARM A : Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks
  • ARM B: MODULEN IBD supplementation (25% of caloric requirements) alone

A Physician not involved in the study design and blinded to the treatment arm will perform the evaluation of the patients during each study visit.

A total of four visits (including final visit) are scheduled for this trial over a period of 12 months at a rhythm of every three months (+/- 2 weeks) for all patients. The study visit will happen during scheduled routine visits, necessary for the routine care of CD patients. Each visit comprises a routine clinical evaluation. The assessment of maintenance of remission is particularly important (wPCDAI<12.5 points), a routine lab analysis including fecal calprotectin is required at each visit. In addition, all relevant medical or other events will be recorded. Only for patients who participate in the annex studies an additional stool sample (microbial analysis) is required. At M9 visit, follow-up endoscopy (M12+/- 6weeks) and entero-MRI (M12+/- 6 weeks) will be programmed as part of the routine surveillance of patients on maintenance therapy, allowing to adjust treatment in the following if necessary. Compliance to treatment will be monitored by recordings of daily MODULEN IBD intake during 2 week periods on the E-system. A quality of life E-questionnaire will be filled out one day prior to each visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Dietary Supplement: MODULEN IBD
    2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).
  • Dietary Supplement: MODULEN IBD
    25% of daily caloric requirements, approx. 500mL/day
Study Arms  ICMJE
  • Experimental: Cyclic exclusive MODULEN IBD
    Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks
    Intervention: Dietary Supplement: MODULEN IBD
  • Experimental: MODULEN IBD supplementation (25% of caloric requirements)
    MODULEN IBD supplementation (25% of caloric requirements) alone A Physician not involved in the study design and blinded to the treatment arm will perform the evaluation of the patients during each study visit.
    Intervention: Dietary Supplement: MODULEN IBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 6-18 years
  • Confirmed Crohn's disease (L1, L2, L3+/- L4a/b)
  • new-onset disease or acute relapse treated with enteral nutrition
  • responding to induction therapy with exclusive enteral nutrition with complete clinical remission at inclusion visit (wPCDAI<12.5)
  • completed cycle of induction therapy of at least 6 weeks (6-12 weeks)
  • biological treatment by Remicade has to be stopped at least 8 weeks prior to inclusion
  • "wash out" of corticosteroids, immunosuppressors and treatment by Humira of minimally 4 weeks prior to inclusion
  • 5-ASA and derivates have to be stopped at least at screening visit
  • Antibiotics must be stopped at least 2 weeks prior to inclusion
  • Informed and signed consent

Exclusion Criteria:

  • Patients with B2 or B3 disease behavior (intestinal/colonic stenosis (including ileo-caecal valve), intrabdominal abscess, fistulizing disease)
  • Patients not in remission on induction therapy (wPCDAI>12.5)
  • Patients with isolated and severe perianal disease
  • Patients requiring surgical therapy at inclusion
  • Ongoing steroid medication
  • Ongoing immunosuppressor or biologics therapy
  • No informed consent
  • Currently participating or having participated in another interventional clinical trial during the last 4 weeks prior to the beginning of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02201693
Other Study ID Numbers  ICMJE P130302
2013-A01473-42 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE GETAID Pediatric
Investigators  ICMJE
Principal Investigator: Franck RUEMMELE, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP