Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease (CD-HOPE)
|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: NCT02201693|
Recruitment Status : Recruiting
First Posted : July 28, 2014
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Dietary Supplement: MODULEN IBD||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease|
|Actual Study Start Date :||December 12, 2014|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Cyclic exclusive MODULEN IBD
Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks
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).
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.
Dietary Supplement: MODULEN IBD
25% of daily caloric requirements, approx. 500mL/day
- The first relapse [ Time Frame: 12 months ]Assessed with wPCDAI
- 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
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): NCT02201693
|Contact: Frank RUEMMELE, MD, PhD||+33 1. email@example.com|
|Contact: Laurence Lecomte||+33 171 firstname.lastname@example.org|
|Hôpital Necker - Enfants Malades||Recruiting|
|Paris, France, 75015|
|Contact: Laurence lecomte, PhD +33 1 71 19 64 94 email@example.com|
|Principal Investigator:||Franck RUEMMELE, MD, PhD||Assistance Publique - Hôpitaux de Paris|