Crohn's DiseaseDIETOMICS-CDNCT02843100
Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease
A study testing Modified Exclusive Enteral Nutrition, Crohn's Disease Exclusion Diet and Partial Enteral Nutrition in people with Crohn's Disease, run by Prof. Arie Levine at 7 sites in 4 countries.
Trial summary
The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Modified Exclusive Enteral Nutrition, Crohn's Disease Exclusion Diet and Partial Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 10 Apr 2018to 29 May 2022
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Established diagnosis of Crohn's disease.
- Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
- Ages 8-18
- Duration of disease ≤ 36 months
- Active inflammation (CRP≥>0.6 mg /dL or ESR≥>20 or Calprotectin≥>200 mcg/gr within the past 3 weeks) during screening
- Patients with B1, P0 uncomplicated disease at enrollment
- Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with left sided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)
- Signed informed consent
Who cannot join
- Patients with very mild disease (PCDAI 12.5 -15) or very severe disease (PCDAI >47.5)
- Pregnancy
- Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
- Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
- Patients with complicated disease (B2, B3)
- Patients who recently onset use of an immunomodulator <8 weeks, or dose change in past 8 weeks.
Show all 11Show fewer
- Patients with current use of biologics, or use in last 8 weeks or current use of systemic steroids
- Patients who have active perianal disease ( active fistula or abscess)
- Patients who have positive stool cultures with relevant pathogens,, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
- Patients with fever > 38.3
- Documented milk protein allergy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Canada3 sites
Dr. Eytan Wine,
Edmonton
Johan Van Limbergen
Halifax
Dr Sally Lawrence
Vancouver
Spain2 sites
Dr. Francisco Javier Martin Carpi
Barcelona
Dr. Víctor Manuel Navas López
Málaga
About this study
Official title: Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.
Read the detailed description
Rational: Exclusive enteral nutrition (EEN) is an established but difficult to perform method for induction of remission and cannot be used for maintenance of remission. It entails drinking only liquid formula for 8 weeks. Refusal to use or to adhere to this therapy is not uncommon and leads to use of other non- dietary strategies in children including steroids and immunosuppression. The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition has been shown to be effective for children with mild to moderate disease. The investigators have developed a maintenance strategy using the CDED.
Objectives: To prove that induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an exclusion diet involving selected table foods.
Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free diet. The study will include a control group of healthy children for microbiome studies.
Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric Crohn's Disease Activity Index (PCDAI)<47.5.
Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks.
Expected outcomes and significance: If this method proves to be equivalent to EEN, the duration of use of EEN will be only two weeks, allowing more patients access to dietary therapy. More importantly, this study will also evaluate two maintenance strategies and will be the first to evaluate re-biosis.
- Conditions
- Crohn's Disease
- Being tested
- Modified Exclusive Enteral Nutrition, Crohn's Disease Exclusion Diet, Partial Enteral Nutrition, Standard Exclusive Enteral Nutrition
- Keywords
- Crohn's Disease, Pediatric, Exclusive Enteral Nutrition, Diet, Microbiome
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Exclusive Enteral NutritionOther
Also called Modulen, Nestle
Two weeks of Exclusive Enteral Nutrition with Modulen
Crohn's Disease Exclusion DietOther
Also called CDED
a limited whole food diet
Partial Enteral NutritionOther
Also called Modulen, Nestle
25-50% of Energy from formula
Standard Exclusive Enteral NutritionOther
Also called Modulen, Nestle
8 weeks of Exclusive Enteral Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Modified Exclusive Enteral Nutrition including two weeks of Exclusive Enteral Nutrition (EEN) using Modulen followed by Partial Enteral Nutrition (PEN) along with the Crohn's Disease Exclusion Diet (CDED) phases 2 \& 3 for 24 weeks Receives: Other: Modified Exclusive Enteral Nutrition; Other: Crohn's Disease Exclusion Diet; Other: Partial Enteral Nutrition |
| Group 2 | Active comparator | Standard Exclusive Enteral Nutrition for 8 weeks using Modulen, followed by free diet with gradual reduction of Modulen to 25% of energy needs by week 24. Receives: Other: Partial Enteral Nutrition; Other: Standard Exclusive Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14
Sustained remission with EEN Vs CDED+PEN
Measured: week 14
Secondary outcomes (6)
ITT steroid free remission at week 8
Induction of remission
Measured: week 8
Microbiome composition difference between groups at week 14
Assessment of microbiome composition and metabolomics
Measured: week 14
3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment
Mucosal healing assessment
Measured: week 24
Steroid and biologic free sustained remission at week 24.
Remission achieved and maintained without additional therapy
Measured: week 14 and 24
Need for additional treatment to achieve remission by week 14
Remission achieved without additional therapy
Measured: Week 14
Mucosal healing as assessed by MRE in dietary responsive disease at week 52
Mucosal healing
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start10 Apr 2018
- Primary completion29 May 2022
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Arie Levine
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Arie Levine, Wolfson Medical Center
- Investigators
- Rotem Sigall Boneh, RD, Principal investigator, Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical CenterMichal Yaakov, Study director, Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843100
- Sponsor's protocol ID
- 0075-16 WOMC
- Acronym
- DIETOMICS-CD
- Status last verified
- May 2022
- First submitted
- 22 Jun 2016
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.
PubMed 24983973Levine 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 31170412Sigall Boneh R, Sarbagili Shabat C, Yanai H, Chermesh I, Ben Avraham S, Boaz M, Levine A. Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. J Crohns Colitis. 2017 Oct 1;11(10):1205-1212. doi: 10.1093/ecco-jcc/jjx071.
PubMed 28525622Sigall Boneh R, Navas-Lopez VM, Hussey S, Pujol-Muncunill G, Lawrence S, Rolandsdotter H, Otley A, Martin-de-Carpi J, Abramas L, Herrador-Lopez M, Egea Castillo N, Chen M, Hurley M, Wingate K, Olen O, Eurenius Raaf T, Yaakov M, Wierdsma N, Van Limbergen J, Wine E. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2001-2011. doi: 10.1016/j.cgh.2024.12.006. Epub 2024 Dec 26.
PubMed 39732356
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
- ClinicalTrials.gov ID
- NCT02843100
- Acronym / sponsor ID
- DIETOMICS-CD / 0075-16 WOMC
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Pediatric, Exclusive Enteral Nutrition, Diet, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Prof. Arie LevineOther government
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 25 Jul 2016 (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 modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.
Detailed description
Rational: Exclusive enteral nutrition (EEN) is an established but difficult to perform method for induction of remission and cannot be used for maintenance of remission. It entails drinking only liquid formula for 8 weeks. Refusal to use or to adhere to this therapy is not uncommon and leads to use of other non- dietary strategies in children including steroids and immunosuppression. The Crohn's Disease Exclusion Diet (CDED) with partial enteral nutrition has been shown to be effective for children with mild to moderate disease. The investigators have developed a maintenance strategy using the CDED.
Objectives: To prove that induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of EEN with Modulen and 12 weeks of an exclusion diet involving selected table foods.
Methods: Open label randomized controlled pilot trial comparing two weeks of EEN followed by the CDED and Partial Enteral Nutrition (PEN), to 8 weeks of EEN followed by PEN with free diet. The study will include a control group of healthy children for microbiome studies.
Population: Age 8-18 years with mild to severe active Crohn's disease defined as 15≤Pediatric Crohn's Disease Activity Index (PCDAI)<47.5.
Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks.
Expected outcomes and significance: If this method proves to be equivalent to EEN, the duration of use of EEN will be only two weeks, allowing more patients access to dietary therapy. More importantly, this study will also evaluate two maintenance strategies and will be the first to evaluate re-biosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Modified Exclusive Enteral Nutrition, Other: Crohn's Disease Exclusion Diet, Other: Partial Enteral NutritionModified Exclusive Enteral Nutrition including two weeks of Exclusive Enteral Nutrition (EEN) using Modulen followed by Partial Enteral Nutrition (PEN) along with the Crohn's Disease Exclusion Diet (CDED) phases 2 \& 3 for 24 weeks |
| Group 2 | Active comparator | Other: Partial Enteral Nutrition, Other: Standard Exclusive Enteral NutritionStandard Exclusive Enteral Nutrition for 8 weeks using Modulen, followed by free diet with gradual reduction of Modulen to 25% of energy needs by week 24. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Established diagnosis of Crohn's disease.
- Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
- Ages 8-18
- Duration of disease ≤ 36 months
- Active inflammation (CRP≥>0.6 mg /dL or ESR≥>20 or Calprotectin≥>200 mcg/gr within the past 3 weeks) during screening
Key exclusion criteria (11 listed)
- Patients with very mild disease (PCDAI 12.5 -15) or very severe disease (PCDAI >47.5)
- Pregnancy
- Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
- Patients who have active extra intestinal disease (such as Arthritis, Uveitis, Pyoderma Gangrenosum, Erythema Nodosum etc.)
- Patients with complicated disease (B2, B3)
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 |
|---|---|---|
| Modified Exclusive Enteral NutritionAlso: Modulen, NestleTwo weeks of Exclusive Enteral Nutrition with Modulen | Other | Group 1 |
| Crohn's Disease Exclusion DietAlso: CDEDa limited whole food diet | Other | Group 1 |
| Partial Enteral NutritionAlso: Modulen, Nestle25-50% of Energy from formula | Other | Group 1, Group 2 |
| Standard Exclusive Enteral NutritionAlso: Modulen, Nestle8 weeks of Exclusive Enteral Nutrition | Other | Group 2 |
Primary outcome
ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14
Time frame: week 14
Sustained remission with EEN Vs CDED+PEN
6 secondary outcomes
ITT steroid free remission at week 8
Time frame: week 8
Microbiome composition difference between groups at week 14
Time frame: week 14
3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment
Time frame: week 24
Steroid and biologic free sustained remission at week 24.
Time frame: week 14 and 24
Need for additional treatment to achieve remission by week 14
Time frame: Week 14
Mucosal healing as assessed by MRE in dietary responsive disease at week 52
Time frame: Week 52
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 1 Jun 2022.
- Background: PubMed 24983973Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.
- 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 28525622Sigall Boneh R, Sarbagili Shabat C, Yanai H, Chermesh I, Ben Avraham S, Boaz M, Levine A. Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. J Crohns Colitis. 2017 Oct 1;11(10):1205-1212. doi: 10.1093/ecco-jcc/jjx071.
- Derived from this study: PubMed 39732356Sigall Boneh R, Navas-Lopez VM, Hussey S, Pujol-Muncunill G, Lawrence S, Rolandsdotter H, Otley A, Martin-de-Carpi J, Abramas L, Herrador-Lopez M, Egea Castillo N, Chen M, Hurley M, Wingate K, Olen O, Eurenius Raaf T, Yaakov M, Wierdsma N, Van Limbergen J, Wine E. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Oct;23(11):2001-2011. doi: 10.1016/j.cgh.2024.12.006. Epub 2024 Dec 26.
- 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.
Rotem Sigall Boneh, RD principal investigator
Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
Michal Yaakov study director
Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Exclusive Enteral Nutrition, Crohn's Disease Exclusion Diet and Partial Enteral Nutrition in people with Crohn's Disease, run by Prof. Arie Levine at 7 sites in 4 countries.
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 8 inclusion and 11 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Spain, Ireland, Israel. 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?
ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14 (time frame: week 14). 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 NCT02843100, which also lists 4 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 1 Jun 2022.