Crohn's DiseaseNCT01728870
Partial Enteral Nutrition With a Unique Diet vs. Exclusive Enteral Nutrition for the Treatment of Pediatric Crohn's Disease
A study testing Unique Diet+Partial Enteral Nutrition and Exclusive Enteral Nutrition (Modulen) in people with Crohn's Disease, run by Prof. Arie Levine at 3 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy and tolerability of a novel dietary intervention for early CD based on partial enteral nutrition, and to compare it to the gold standard but difficult to implement dietary intervention- Exclusive enteral nutrition with Modulen . Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Unique Diet+Partial Enteral Nutrition and Exclusive Enteral Nutrition (Modulen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2013to Jul 2018
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 4-18 years of age.
- Patients with a diagnosis of CD-duration of disease up to 36 months
- Have macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon
- Patients with a pediatric activity index -PCDAI ≥ 10
- Patients will not be excluded if they have received 5ASA or an immunomodulator for >8 weeks and the dose is stable , or if they start a thiopurine concurrently , as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy.
- Informed Consent
Who cannot join
- Patients with no disease activity ( PCDAI <10) or severe disease ( PCDAI ≥ 40).
- Patients who have received corticosteroids of any kind in the previous 4 weeks.
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological treatment
- Isolated Large bowel disease ( L2) involving the recto-sigmoid or descending colon
- Patients with penetrating disease (abscess or fistula)
Show all 13Show fewer
- Active Perianal disease
- Fixed stricture or small bowel obstruction
- Normal CRP and ESR
- Active joint disease.
- Patients who have undergone an intestinal resection.
- Sclerosing Cholangitis
- Pregnancy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G 1C9
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: Comparison of Partial Enteral Nutririon (Modulen) With a Unique Diet to Exclusive Enteral Nutrition (Modulen) for the Treatment of Pediatric Crohn's Disease. A Prospective Randomized Controlled Trial.
The purpose of this study is to assess the efficacy and tolerability of a novel dietary intervention for early CD based on partial enteral nutrition, and to compare it to the gold standard but difficult to implement dietary intervention- Exclusive enteral nutrition with Modulen .
Read the detailed description
Background: Crohn's disease is clearly on the rise in countries exposed to industrialization and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease activity. The strongest argument for an effect of diet is the effect of exclusive enteral nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet, irrespective of which diet, will enter complete remission, often with normalization of inflammatory markers. The effect of formula has been shown to be independent of fat or protein composition in pediatric studies, but to be dependent on exclusion of normal diet.Thus, rather than the composition of EEN being associated with remission of disease it may be the exclusion of certain components of the Western diet may be responsible for improvement.
Methods:This is a prospective randomized controlled trial, in patients with a recent diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.
Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle) and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6 weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization) will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups. Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but continue restricted diet.
Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.
We hypothesize that by withdrawing the offending dietary agents we can achieve an equal remission rate with improved tolerability. This study will evaluate response, remission and tolerability in both groups, as well as the effects of nutrition on bone health.
- Conditions
- Crohn's Disease
- Being tested
- Unique Diet+Partial Enteral Nutrition, Exclusive Enteral Nutrition (Modulen)
- Keywords
- Pediatric, Crohn's disease, Mild to moderate Crohn's Disease, Diet, Enteral Nutrition
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unique Diet+Partial Enteral NutritionOther
Also called Modulen, Nestle
Modulen - liquid dietary formula
Exclusive Enteral Nutrition (Modulen)Other
Also called Modulen, Nestle
| Study group | Role | What they receive |
|---|---|---|
| Unique Diet+Partial Enteral Nutrition | Experimental | Unique Diet+Partial Enteral Nutrition (PEN): This group will receive as follows:
Weeks 1-6: 50% of dietary needs from PEN (Modulen, Nestle) and 50% from a limited whole food diet.
Weeks 7-12: 25% of dietary needs from PEN (Modulen, Nestle) and 75% from a limited whole food diet. Receives: Other: Unique Diet+Partial Enteral Nutrition |
| Exclusive Enteral Nutrition (Modulen) | Active comparator | Exclusive Enteral Nutrition(EEN): This group will receive as follows:
Weeks 1-6: EEN(100% of dietary needs from Modulen) Weeks 7-12: 25% of dietary needs from Modulen and 75% from a free diet. Receives: Other: Exclusive Enteral Nutrition (Modulen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire
Measured: 6 weeks
Secondary outcomes (5)
Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.
Measured: 6 weeks
Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component),
Measured: 6 weeks and 12 weeks
Bone health
change in serum bone biomarkers from baseline and their correlation with DEXA (optional)
Measured: at the 3, and 6 month visits
CRP at week 12
Measured: 12 weeks
Physician assessment of compliance
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2018
- Study completionJul 2018
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.
- 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
- 74 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
- Arie Levine, MD, Principal investigator, Pediatric Gastroenterology and Nutrition unit, Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728870
- Sponsor's protocol ID
- 0164-12-WOMC
- Status last verified
- Jul 2018
- First submitted
- 13 Nov 2012
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sigall Boneh R, van der Kruk N, Wine E, Verburgt CM, de Meij TGJ, Lowenberg M, Gecse KB, Wierdsma N, Derikx JPM, de Jonge WJ, D'Haens G, Ghiboub M, Van Limbergen JE. Tryptophan metabolites profile predict remission with dietary therapy in pediatric Crohn's disease. Ther Adv Gastroenterol. 2025 Feb 25;18:17562848251323004. doi: 10.1177/17562848251323004. eCollection 2025.
PubMed 40012837Verburgt CM, Dunn KA, Ghiboub M, Lewis JD, Wine E, Sigall Boneh R, Gerasimidis K, Shamir R, Penny S, Pinto DM, Cohen A, Bjorndahl P, Svolos V, Bielawski JP, Benninga MA, de Jonge WJ, Van Limbergen JE. Successful Dietary Therapy in Paediatric Crohn's Disease is Associated with Shifts in Bacterial Dysbiosis and Inflammatory Metabotype Towards Healthy Controls. J Crohns Colitis. 2023 Jan 27;17(1):61-72. doi: 10.1093/ecco-jcc/jjac105.
PubMed 36106847Ghiboub M, Penny S, Verburgt CM, Boneh RS, Wine E, Cohen A, Dunn KA, Pinto DM, Benninga MA, de Jonge WJ, Levine A, Van Limbergen JE. Metabolome Changes With Diet-Induced Remission in Pediatric Crohn's Disease. Gastroenterology. 2022 Oct;163(4):922-936.e15. doi: 10.1053/j.gastro.2022.05.050. Epub 2022 Jun 7.
PubMed 35679949Sigall Boneh R, Van Limbergen J, Wine E, Assa A, Shaoul R, Milman P, Cohen S, Kori M, Peleg S, On A, Shamaly H, Abramas L, Levine A. Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease. Clin Gastroenterol Hepatol. 2021 Apr;19(4):752-759. doi: 10.1016/j.cgh.2020.04.006. Epub 2020 Apr 14.
PubMed 32302709Levine 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 31170412
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Partial Enteral Nutririon (Modulen) With a Unique Diet to Exclusive Enteral Nutrition (Modulen) for the Treatment of Pediatric Crohn's Disease. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01728870
- Acronym / sponsor ID
- 0164-12-WOMC
- Conditions
- Crohn's Disease
- Keywords
- Pediatric, Crohn's disease, Mild to moderate Crohn's Disease, Diet, Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Prof. Arie LevineOther government
- Study start
- Jan 2013
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Nov 2012 (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 assess the efficacy and tolerability of a novel dietary intervention for early CD based on partial enteral nutrition, and to compare it to the gold standard but difficult to implement dietary intervention- Exclusive enteral nutrition with Modulen .
Detailed description
Background: Crohn's disease is clearly on the rise in countries exposed to industrialization and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease activity. The strongest argument for an effect of diet is the effect of exclusive enteral nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet, irrespective of which diet, will enter complete remission, often with normalization of inflammatory markers. The effect of formula has been shown to be independent of fat or protein composition in pediatric studies, but to be dependent on exclusion of normal diet.Thus, rather than the composition of EEN being associated with remission of disease it may be the exclusion of certain components of the Western diet may be responsible for improvement.
Methods:This is a prospective randomized controlled trial, in patients with a recent diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.
Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle) and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6 weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization) will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups. Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but continue restricted diet.
Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.
We hypothesize that by withdrawing the offending dietary agents we can achieve an equal remission rate with improved tolerability. This study will evaluate response, remission and tolerability in both groups, as well as the effects of nutrition on bone health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unique Diet+Partial Enteral Nutrition | Experimental | Other: Unique Diet+Partial Enteral NutritionUnique Diet+Partial Enteral Nutrition (PEN): This group will receive as follows: Weeks 1-6: 50% of dietary needs from PEN (Modulen, Nestle) and 50% from a limited whole food diet. Weeks 7-12: 25% of dietary needs from PEN (Modulen, Nestle) and 75% from a limited whole food diet. |
| Exclusive Enteral Nutrition (Modulen) | Active comparator | Other: Exclusive Enteral Nutrition (Modulen)Exclusive Enteral Nutrition(EEN): This group will receive as follows: Weeks 1-6: EEN(100% of dietary needs from Modulen) Weeks 7-12: 25% of dietary needs from Modulen and 75% from a free diet. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children 4-18 years of age.
- Patients with a diagnosis of CD-duration of disease up to 36 months
- Have macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon
- Patients with a pediatric activity index -PCDAI ≥ 10
- Patients will not be excluded if they have received 5ASA or an immunomodulator for >8 weeks and the dose is stable , or if they start a thiopurine concurrently , as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy.
Key exclusion criteria (13 listed)
- Patients with no disease activity ( PCDAI <10) or severe disease ( PCDAI ≥ 40).
- Patients who have received corticosteroids of any kind in the previous 4 weeks.
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological treatment
- Isolated Large bowel disease ( L2) involving the recto-sigmoid or descending colon
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 |
|---|---|---|
| Unique Diet+Partial Enteral NutritionAlso: Modulen, NestleModulen - liquid dietary formula | Other | Unique Diet+Partial Enteral Nutrition |
| Exclusive Enteral Nutrition (Modulen)Also: Modulen, Nestle | Other | Exclusive Enteral Nutrition (Modulen) |
Primary outcome
patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire
Time frame: 6 weeks
5 secondary outcomes
Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.
Time frame: 6 weeks
Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component),
Time frame: 6 weeks and 12 weeks
Bone health
Time frame: at the 3, and 6 month visits
CRP at week 12
Time frame: 12 weeks
Physician assessment of compliance
Time frame: 6 weeks
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 6 Jul 2018.
- Derived from this study: PubMed 40012837Sigall Boneh R, van der Kruk N, Wine E, Verburgt CM, de Meij TGJ, Lowenberg M, Gecse KB, Wierdsma N, Derikx JPM, de Jonge WJ, D'Haens G, Ghiboub M, Van Limbergen JE. Tryptophan metabolites profile predict remission with dietary therapy in pediatric Crohn's disease. Ther Adv Gastroenterol. 2025 Feb 25;18:17562848251323004. doi: 10.1177/17562848251323004. eCollection 2025.
- Derived from this study: PubMed 36106847Verburgt CM, Dunn KA, Ghiboub M, Lewis JD, Wine E, Sigall Boneh R, Gerasimidis K, Shamir R, Penny S, Pinto DM, Cohen A, Bjorndahl P, Svolos V, Bielawski JP, Benninga MA, de Jonge WJ, Van Limbergen JE. Successful Dietary Therapy in Paediatric Crohn's Disease is Associated with Shifts in Bacterial Dysbiosis and Inflammatory Metabotype Towards Healthy Controls. J Crohns Colitis. 2023 Jan 27;17(1):61-72. doi: 10.1093/ecco-jcc/jjac105.
- Derived from this study: PubMed 35679949Ghiboub M, Penny S, Verburgt CM, Boneh RS, Wine E, Cohen A, Dunn KA, Pinto DM, Benninga MA, de Jonge WJ, Levine A, Van Limbergen JE. Metabolome Changes With Diet-Induced Remission in Pediatric Crohn's Disease. Gastroenterology. 2022 Oct;163(4):922-936.e15. doi: 10.1053/j.gastro.2022.05.050. Epub 2022 Jun 7.
- Derived from this study: PubMed 32302709Sigall Boneh R, Van Limbergen J, Wine E, Assa A, Shaoul R, Milman P, Cohen S, Kori M, Peleg S, On A, Shamaly H, Abramas L, Levine A. Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease. Clin Gastroenterol Hepatol. 2021 Apr;19(4):752-759. doi: 10.1016/j.cgh.2020.04.006. Epub 2020 Apr 14.
- Derived from this study: 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.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Arie Levine, MD principal investigator
Pediatric Gastroenterology and Nutrition unit, Wolfson MC
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unique Diet+Partial Enteral Nutrition and Exclusive Enteral Nutrition (Modulen) in people with Crohn's Disease, run by Prof. Arie Levine at 3 sites in 2 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 6 inclusion and 13 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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?
patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire (time frame: 6 weeks). 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 NCT01728870, 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 6 Jul 2018.