Crohn's DiseaseCD-HOPENCT02201693
Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
A study testing MODULEN IBD in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- MODULEN IBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2014to 2 Oct 2019
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- "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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
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).
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- MODULEN IBD
- Keywords
- Crohn's disease,, pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),, enteral nutrition,, randomized multicenter study
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODULEN IBDDietary supplement
2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).
MODULEN IBDDietary supplement
25% of daily caloric requirements, approx. 500mL/day
| Study group | Role | What they receive |
|---|---|---|
| Cyclic exclusive MODULEN IBD | Experimental | Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks Receives: Dietary Supplement: MODULEN IBD |
| MODULEN IBD supplementation (25% of caloric requirements) | Experimental | 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. Receives: Dietary Supplement: MODULEN IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first relapse
Assessed with wPCDAI
Measured: 12 months
Secondary outcomes (8)
Clinical remission
Assessed with wPCDAI, CDAI, PGA
Measured: 12 months
Time to the first relapse
Assessed with wPCDAI, CDAI, PGA
Measured: until month 12
Variation of wPCDAI,
Assessed with wPCDAI
Measured: until month12
Endoscopic remission
CDEIS
Measured: month 12
Transmural healing
MRI
Measured: Month 12
Calprotectin
Fecal sample
Measured: until month12
Quality of life analysis
E-questionnaire
Measured: Until Month 12
Growth pattern
Z-Score
Measured: Until Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start12 Dec 2014
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GETAID Pediatric, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Franck RUEMMELE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201693
- Sponsor's protocol ID
- P130302
- Other IDs
- 2013-A01473-42
- Acronym
- CD-HOPE
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2014
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pigneur B, Martinez-Vinson C, Bourmaud A, Dabadie A, Duclaux-Loras R, Hugot JP, Roman C, Dumant C, Spyckerelle C, Guinard-Samuel V, Willot S, Dupont C, Breton A, Caron N, Chaillou E, Rebouissoux L, Bertrand V, Triolo V, Pages J, Djeddi D, Bonneton M, Uhlen S, Catteau N, Coopman S, Lepage P, Viala J, Ruemmele FM. Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):204-217. doi: 10.1016/S2468-1253(25)00262-6. Epub 2026 Jan 19.
PubMed 41570843
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT02201693
- Acronym / sponsor ID
- CD-HOPE / P130302
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease,, pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),, enteral nutrition,, randomized multicenter study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GETAID Pediatric, URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 28 Jul 2014 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclic exclusive MODULEN IBD | Experimental | Dietary Supplement: MODULEN IBDCyclic exclusive MODULEN IBD for 2 weeks every 8 weeks |
| MODULEN IBD supplementation (25% of caloric requirements) | Experimental | Dietary Supplement: MODULEN IBDMODULEN 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| MODULEN IBD2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day). | Dietary supplement | Cyclic exclusive MODULEN IBD |
| MODULEN IBD25% of daily caloric requirements, approx. 500mL/day | Dietary supplement | MODULEN IBD supplementation (25% of caloric requirements) |
Primary outcome
The first relapse
Time frame: 12 months
Assessed with wPCDAI
8 secondary outcomes
Clinical remission
Time frame: 12 months
Time to the first relapse
Time frame: until month 12
Variation of wPCDAI,
Time frame: until month12
Endoscopic remission
Time frame: month 12
Transmural healing
Time frame: Month 12
Calprotectin
Time frame: until month12
Quality of life analysis
Time frame: Until Month 12
Growth pattern
Time frame: Until Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 41570843Pigneur B, Martinez-Vinson C, Bourmaud A, Dabadie A, Duclaux-Loras R, Hugot JP, Roman C, Dumant C, Spyckerelle C, Guinard-Samuel V, Willot S, Dupont C, Breton A, Caron N, Chaillou E, Rebouissoux L, Bertrand V, Triolo V, Pages J, Djeddi D, Bonneton M, Uhlen S, Catteau N, Coopman S, Lepage P, Viala J, Ruemmele FM. Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):204-217. doi: 10.1016/S2468-1253(25)00262-6. Epub 2026 Jan 19.
- Individual participant dataSharing planned: No
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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.
Franck RUEMMELE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MODULEN IBD in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first relapse (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201693, which also lists 1 linked publication.
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 30 Mar 2026.