Crohn's DiseasePhase 3ASCENSIONNCT04777656
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
A Phase 3 study testing Phase1 : CDED/Modulen™IBD® + Maintenance therapy and Phase2 and 3 : in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Phase1 : CDED/Modulen™IBD® + Maintenance therapy and Phase2 and 3 :
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Sep 2022to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI >12.5 or CRP > 2 times upper limit or calprotectin levels >250µg/g if available) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies)
- For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom)
- Patient willing to comply with daily intake of an exclusion diet
- Informed and signed consent of parents
- Patient affiliated to social security (or health insurance)
Who cannot join
- Active perianal fistulizing disease
- Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon
- Patient who require CD-related surgical therapy
- Patient with known allergy to cow milk's proteins
- Patient incapable to follow CDED for a prolonged period
- Pregnancy, breastfeeding
- Patient already included in an interventional study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hôpital Femme mère enfant, CHU Lyon - Service Hépato-gastroentérologie et Nutrition pédiatrique
Bron, 69677
Rémi Duclaux-Loras, MD, PhD, +33-4-72-35-70-50, remi.duclaux-loras@chu-lyon.fr
- Recruiting
CHU Caen Normandie - Service de Gastroentérologie pédiatrique
Caen, 14033
Claire Dupont-Lucas, MD, PhD, +33-2-31-27-25-94, dupont-c@chu-caen.fr
- Recruiting
Hôpital de la Timone, AP-HM - Service de Gastroentérologie pédiatrique
Marseille, 13385
Céline Roman, MD, PhD, +33-4-91-38-83-83, celine.roman@ap-hm.fr
- Recruiting
Hôpital Necker-Enfants malades - Service de Gastroentérologie pédiatrique
Paris, 75015
Franck Ruemmele, MD, PhD, +33 (0)1 44 49 25 16, frank.ruemmele@aphp.fr
About this study
Official title: Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.
This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED
Read the detailed description
Crohn's disease is a recurrent inflammatory disorder. Current treatment strategies aim reducing intestinal (and systemic) inflammation based on the use of Immunomodulators (IM) and biologics (B). However, some patients, particularly in the pediatric age group do not respond with remission to standard therapy and approximately 30% of patients lose response to efficient therapy. There is a clear unmet need for new treatment strategies. In addition, patients and families have a high degree of reluctance to use IM/B as life-long medication, particularly due to potential side effects including cancer, lymphomas, serious infections or drug-related immune diseases. This is of particular importance for children/adolescents with CD, potentially exposed over many decades to various IM/B. Experimental and epidemiological data indicate that the western life style and particularly modern food play a key role in the development of CD, probably via alteration of the intestinal barrier function and/or enforcing the intestinal dysbiosis. Based on these data and the observation that exclusive enteral nutrition is highly efficacious in inducing remission in active CD, nutritional therapies are more and more in the focus for the development of new treatment approaches.
The main objective is to assess if the addition of CDED to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED.
To achieve this objective, eligible patients with active CD will participate to this study for a 13 months period. After a screening period, the patients will have a 2 months run-in phase where they will follow the CDED protocol, but continue their maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped at the end of the 2 months.
Then, the patients responding to CDED during run-in will be randomized at M2 to one of the two treatment arms (CDED/Modulen™IBD® or Unrestricted food access) and will have 4 follow-up visits (M4, M6, M9 and M12)
- Conditions
- Crohn's Disease
- Being tested
- Phase1 : CDED/Modulen™IBD® + Maintenance therapy, Phase2 and 3 :
- Keywords
- Crohn's disease, Recurrent inflammatory disorder, Immunomodulators, Biologics, Exclusive Enteral Nutrition, Crohn's disease exclusion diet (CDED), Modulen™IBD®
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase1 : CDED/Modulen™IBD® + Maintenance therapyDietary supplement
from D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.)
Phase2 and 3 :Dietary supplement
Also called CDED/Modulen™IBD® + Maintenance therapy
from M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods).
| Study group | Role | What they receive |
|---|---|---|
| CDED/Modulen™IBD® | Experimental | Strategy combining CD exclusion diet plus Modulen™IBD® on top of ongoing maintenance therapy. Receives: Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy; Dietary Supplement: Phase2 and 3 : |
| Unrestricted food access | Active comparator | Stop CDED and Modulen™IBD®, but continue maintenance therapy with unrestricted food access. Receives: Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy |
| Not randomized | Other | Patient not in remission at M2 or refusing randomisation Receives: Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse from randomization until M12
Relapse is defined as weighted Paediatric Crohn's disease activity index (wPCDAI) >40 points and/or CRP >2 times over upper limit (in the absence of any obvious infections sign) or if at two consecutive visits (within 2-8 weeks) the wPCDAI is >12,5 but less 40 and/or CRP >1,5 but less 2 times over upper limit (in the absence of any obvious infections sign) or if the patient required additional CD-specific medication/surgery in the interval.
Measured: 12 months
Secondary outcomes (22)
Change of wPCDAI from baseline to M2
Measured: 2 months
Change of fecal calprotectin values from baseline to M2
Measured: 2 months
Clinical remission at M2
Defined as wPCDAI ≤12.5 and normal CRP (≤1.5 fold upper normal range)
Measured: 2 months
Deep remission at M2
Defined as wPCDAI ≤12.5 and normal CRP within normal lab range) and normal fecal calprotectin ((<250µg/g)
Measured: 2 months
Physician global assessment (PGA) from baseline to M2
Crohn's Disease activity assessed as remission - weak - moderate - severe
Measured: 2 months
Mucosal healing at M2
absence of any ulcerations (including aphthae)
Measured: 2 months
Endoscopic response at M2
Decrease of Crohn's Disease Endoscopic Index Score (CDEIS) ≥ 50% from baseline
Measured: 2 months
Change of MRI from baseline to M2
Simplified Magnetic Resonance Index of Activity (MARIA) for Crohn's Disease score from baseline to M2
Measured: 2 months
CDED tolerance rate at M2
serious and non serious adverse events
Measured: 2 months
CDED compliance rate at M2
Measured: 2 months
Change of intestinal microbiome composition from baseline to M2
Measured: 2 months
Clinical remission
Defined as wPCDAI ≤12.5 and normal CRP (≤1.5 fold upper normal range)
Measured: At 4 months, 6 months, 9 months and 12 months
Deep remission
Defined as wPCDAI ≤12.5 and normal CRP (within normal lab range) and normal fecal calprotectin (<250µg/g)
Measured: At 4 months, 6 months, 9 months and 12 months
Relapse
Defined as wPCDAI >40 points and/or CRP >2 times over upper limit (in the absence of any obvious infections sign) or if at two consecutive visits (within 2-8 weeks) the wPCDAI is >12,5 but less 40 and/or CRP >1,5 but less 2 times over upper limit (in the absence of any obvious infections sign) or if the patient required additional CD-specific medication/surgery in the interval
Measured: At 4 months, 6 months, 9 months and 12 months
Physician global assessment (PGA)
Crohn's Disease activity assessed as remission - weak - moderate - severe
Measured: At 4 months, 6 months, 9 months and 12 months
Mucosal Healing at M12
Absence of any ulcerations (including aphthae)
Measured: 12 months
Endoscopic response at M12
Decrease of Crohn's Disease Endoscopic Index Score (CDEIS) ≥ 50% from baseline
Measured: 12 months
Change of MRI from M2 to M12
Simplified Magnetic Resonance Index of Activity (MARIA) for Crohn's Disease score from M2 to M12
Measured: 12 months
CDED tolerance rate at M12
Serious and non serious adverse events
Measured: 12 months
CDED compliance rate at M12
Measured: 12 months
Change of Intestinal microbiome composition
Measured: At 4 months, 6 months, 9 months, 12 months
Change of quality of life IMPACT-3 from inclusion until 12 months
IMPACT-3 questionnaire of 35 closed questions - scale ranging from 1 to 5 for all answers - higher score suggesting better quality of life
Measured: At baseline, 2 months, 4 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start26 Sep 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- MICALIS Institute, 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
- NCT04777656
- Sponsor's protocol ID
- APHP200010
- Other IDs
- 2020-A02569-30
- Acronym
- ASCENSION
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martin-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas Lopez VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6.
PubMed 24909831Wynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cezard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.
PubMed 18376247Pigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Dore J, Ruemmele FM. Mucosal Healing and Bacterial Composition in Response to Enteral Nutrition Vs Steroid-based Induction Therapy-A Randomised Prospective Clinical Trial in Children With Crohn's Disease. J Crohns Colitis. 2019 Jul 25;13(7):846-855. doi: 10.1093/ecco-jcc/jjy207.
PubMed 30541015Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.
PubMed 31170412Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.
PubMed 29777041
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone.
- ClinicalTrials.gov ID
- NCT04777656
- Acronym / sponsor ID
- ASCENSION / APHP200010
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Recurrent inflammatory disorder, Immunomodulators, Biologics, Exclusive Enteral Nutrition, Crohn's disease exclusion diet (CDED), Modulen™IBD®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- MICALIS Institute, URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Mar 2021 (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.
This research is a multicenter French randomized and single blinded phase III clinical trial evaluating two treatment strategies among Crohn's disease (CD) patients. The main objective is to assess if the addition of Crohn's Disease Exclusion Diet (CDED) to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED
Detailed description
Crohn's disease is a recurrent inflammatory disorder. Current treatment strategies aim reducing intestinal (and systemic) inflammation based on the use of Immunomodulators (IM) and biologics (B). However, some patients, particularly in the pediatric age group do not respond with remission to standard therapy and approximately 30% of patients lose response to efficient therapy. There is a clear unmet need for new treatment strategies. In addition, patients and families have a high degree of reluctance to use IM/B as life-long medication, particularly due to potential side effects including cancer, lymphomas, serious infections or drug-related immune diseases. This is of particular importance for children/adolescents with CD, potentially exposed over many decades to various IM/B. Experimental and epidemiological data indicate that the western life style and particularly modern food play a key role in the development of CD, probably via alteration of the intestinal barrier function and/or enforcing the intestinal dysbiosis. Based on these data and the observation that exclusive enteral nutrition is highly efficacious in inducing remission in active CD, nutritional therapies are more and more in the focus for the development of new treatment approaches.
The main objective is to assess if the addition of CDED to ongoing standard medication is superior to reduce the rate of relapses over 12 months compared to standard medication alone in children/adolescents with unstable CD responding with remission after a 2-months course of CDED.
To achieve this objective, eligible patients with active CD will participate to this study for a 13 months period. After a screening period, the patients will have a 2 months run-in phase where they will follow the CDED protocol, but continue their maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped at the end of the 2 months.
Then, the patients responding to CDED during run-in will be randomized at M2 to one of the two treatment arms (CDED/Modulen™IBD® or Unrestricted food access) and will have 4 follow-up visits (M4, M6, M9 and M12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDED/Modulen™IBD® | Experimental | Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy, Dietary Supplement: Phase2 and 3 :Strategy combining CD exclusion diet plus Modulen™IBD® on top of ongoing maintenance therapy. |
| Unrestricted food access | Active comparator | Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapyStop CDED and Modulen™IBD®, but continue maintenance therapy with unrestricted food access. |
| Not randomized | Other | Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapyPatient not in remission at M2 or refusing randomisation |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child/Adolescent aged 6-17 years with a confirmed diagnosis of CD (for at least 3 months) with an active disease (defined as: wPCDAI >12.5 or CRP > 2 times upper limit or calprotectin levels >250µg/g if available) despite anti-inflammatory (5-ASA and derivates), corticosteroids, immunomodulator (thiopurines or methotrexate) and/or biologic therapy (anti-TNF, anti-integrin anti-IL23 antibodies)
- For girls of childbearing age: a negative pregnancy test, and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom)
- Patient willing to comply with daily intake of an exclusion diet
- Informed and signed consent of parents
- Patient affiliated to social security (or health insurance)
Key exclusion criteria (7 listed)
- Active perianal fistulizing disease
- Internal fistula or evidence of un-drained and un-controlled abscess/phlegmon
- Patient who require CD-related surgical therapy
- Patient with known allergy to cow milk's proteins
- Patient incapable to follow CDED for a prolonged period
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 |
|---|---|---|
| Phase1 : CDED/Modulen™IBD® + Maintenance therapyfrom D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.) | Dietary supplement | CDED/Modulen™IBD®, Not randomized, Unrestricted food access |
| Phase2 and 3 :Also: CDED/Modulen™IBD® + Maintenance therapyfrom M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods). | Dietary supplement | CDED/Modulen™IBD® |
Primary outcome
Relapse from randomization until M12
Time frame: 12 months
Relapse is defined as weighted Paediatric Crohn's disease activity index (wPCDAI) >40 points and/or CRP >2 times over upper limit (in the absence of any obvious infections sign) or if at two consecutive visits (within 2-8 weeks) the wPCDAI is >12,5 but less 40 and/or CRP >1,5 but less 2 times over upper limit (in the absence of any obvious infections sign) or if the patient required additional CD-specific medication/surgery in the interval.
22 secondary outcomes
Change of wPCDAI from baseline to M2
Time frame: 2 months
Change of fecal calprotectin values from baseline to M2
Time frame: 2 months
Clinical remission at M2
Time frame: 2 months
Deep remission at M2
Time frame: 2 months
Physician global assessment (PGA) from baseline to M2
Time frame: 2 months
Mucosal healing at M2
Time frame: 2 months
Endoscopic response at M2
Time frame: 2 months
Change of MRI from baseline to M2
Time frame: 2 months
CDED tolerance rate at M2
Time frame: 2 months
CDED compliance rate at M2
Time frame: 2 months
Change of intestinal microbiome composition from baseline to M2
Time frame: 2 months
Clinical remission
Time frame: At 4 months, 6 months, 9 months and 12 months
Deep remission
Time frame: At 4 months, 6 months, 9 months and 12 months
Relapse
Time frame: At 4 months, 6 months, 9 months and 12 months
Physician global assessment (PGA)
Time frame: At 4 months, 6 months, 9 months and 12 months
Mucosal Healing at M12
Time frame: 12 months
Endoscopic response at M12
Time frame: 12 months
Change of MRI from M2 to M12
Time frame: 12 months
CDED tolerance rate at M12
Time frame: 12 months
CDED compliance rate at M12
Time frame: 12 months
Change of Intestinal microbiome composition
Time frame: At 4 months, 6 months, 9 months, 12 months
Change of quality of life IMPACT-3 from inclusion until 12 months
Time frame: At baseline, 2 months, 4 months, 6 months, 9 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 24909831Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J, Barabino A, Braegger CP, Bronsky J, Buderus S, Martin-de-Carpi J, De Ridder L, Fagerberg UL, Hugot JP, Kierkus J, Kolacek S, Koletzko S, Lionetti P, Miele E, Navas Lopez VM, Paerregaard A, Russell RK, Serban DE, Shaoul R, Van Rheenen P, Veereman G, Weiss B, Wilson D, Dignass A, Eliakim A, Winter H, Turner D; European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease. J Crohns Colitis. 2014 Oct;8(10):1179-207. doi: 10.1016/j.crohns.2014.04.005. Epub 2014 Jun 6.
- Background: PubMed 18376247Wynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cezard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.
- Background: PubMed 30541015Pigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Dore J, Ruemmele FM. Mucosal Healing and Bacterial Composition in Response to Enteral Nutrition Vs Steroid-based Induction Therapy-A Randomised Prospective Clinical Trial in Children With Crohn's Disease. J Crohns Colitis. 2019 Jul 25;13(7):846-855. doi: 10.1093/ecco-jcc/jjy207.
- Background: PubMed 31170412Levine A, Wine E, Assa A, Sigall Boneh R, Shaoul R, Kori M, Cohen S, Peleg S, Shamaly H, On A, Millman P, Abramas L, Ziv-Baran T, Grant S, Abitbol G, Dunn KA, Bielawski JP, Van Limbergen J. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019 Aug;157(2):440-450.e8. doi: 10.1053/j.gastro.2019.04.021. Epub 2019 Jun 4.
- Background: PubMed 29777041Levine A, Sigall Boneh R, Wine E. Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases. Gut. 2018 Sep;67(9):1726-1738. doi: 10.1136/gutjnl-2017-315866. Epub 2018 May 18.
- 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.
Franck Ruemmele, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phase1 : CDED/Modulen™IBD® + Maintenance therapy and Phase2 and 3 : in people with Crohn's Disease, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 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 4 sites 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.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Franck Ruemmele, MD, PhD (+33 (0)1 44 49 25 16, frank.ruemmele@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse from randomization until M12 (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 NCT04777656, which also lists 5 linked publications.
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 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.