Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease (CD-HOPE)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MODULEN IBD
MODULEN IBD
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease,, pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),, enteral nutrition,, randomized multicenter study
Eligibility Criteria
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
Sites / Locations
- Hôpital Necker - Enfants Malades
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cyclic exclusive MODULEN IBD
MODULEN IBD supplementation (25% of caloric requirements)
Arm Description
Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks
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.
Outcomes
Primary Outcome Measures
The first relapse
Assessed with wPCDAI
Secondary Outcome Measures
Clinical remission
Assessed with wPCDAI, CDAI, PGA
Time to the first relapse
Assessed with wPCDAI, CDAI, PGA
Variation of wPCDAI,
Assessed with wPCDAI
Endoscopic remission
CDEIS
Transmural healing
MRI
Calprotectin
Fecal sample
Quality of life analysis
E-questionnaire
Growth pattern
Z-Score
Full Information
NCT ID
NCT02201693
First Posted
July 17, 2014
Last Updated
April 13, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GETAID Pediatric
1. Study Identification
Unique Protocol Identification Number
NCT02201693
Brief Title
Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Acronym
CD-HOPE
Official Title
Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2014 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
GETAID Pediatric
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease,, pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),, enteral nutrition,, randomized multicenter study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyclic exclusive MODULEN IBD
Arm Type
Experimental
Arm Description
Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks
Arm Title
MODULEN IBD supplementation (25% of caloric requirements)
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
MODULEN IBD
Intervention Description
2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).
Intervention Type
Dietary Supplement
Intervention Name(s)
MODULEN IBD
Intervention Description
25% of daily caloric requirements, approx. 500mL/day
Primary Outcome Measure Information:
Title
The first relapse
Description
Assessed with wPCDAI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical remission
Description
Assessed with wPCDAI, CDAI, PGA
Time Frame
12 months
Title
Time to the first relapse
Description
Assessed with wPCDAI, CDAI, PGA
Time Frame
until month 12
Title
Variation of wPCDAI,
Description
Assessed with wPCDAI
Time Frame
until month12
Title
Endoscopic remission
Description
CDEIS
Time Frame
month 12
Title
Transmural healing
Description
MRI
Time Frame
Month 12
Title
Calprotectin
Description
Fecal sample
Time Frame
until month12
Title
Quality of life analysis
Description
E-questionnaire
Time Frame
Until Month 12
Title
Growth pattern
Description
Z-Score
Time Frame
Until Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck RUEMMELE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
We'll reach out to this number within 24 hrs