Crohn's DiseaseCDED-ADNCT02231814
The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease
A study testing Crohns Disease Exclusion Diet + PEN and Crohns Disease Exclusion Diet in people with Crohn's Disease, run by Prof. Arie Levine at 4 sites in Israel.
Trial summary
This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Crohns Disease Exclusion Diet + PEN and Crohns Disease Exclusion Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesIsrael
- Study dates
- Dec 2016to Dec 2020
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- Established Crohn's disease
- Aged 18-55
- Duration of disease up to 5 years
- Harvey Bradshaw Index 5 ≤( HBI) ≤15
- Patients with uncomplicated disease involving the terminal ileum and or cecum
- Patients who performed colonoscopy (or MR/CTEnterography with elevated calprotectin>200) demonstrating active disease in the previous 8 weeks
Who cannot join
- Patients with severe Disease (HBI > 15) or HBI<5
- Pregnancy,
- Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease,
- Patients who used immunomodulator <8 weeks, or had dose changed in past 8 weeks,
- Patients with current or past use of biologics, or use of systemic steroids2,
- Patients with deep ulcers involving the colon distal to the splenic flexure on most recent colonoscopy
Show all 16Show fewer
- Any proven current infection such as positive stool cultures or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
- Active Perianal disease ( clarification-fistula with discharge or abscess)
- Patients who have undergone an intestinal resection
- Patients with systemic disease including: type 2 diabetes, kidney failure, liver failure, neurological disease, active heart disease and patients with active autoimmune condition requiring medication3
- Patients unwilling to consume any animal source protein (eggs, chicken or fish).
- Comments:
- Patients with ileo-cecal valve narrowing maybe included
- Patients active despite budesonide may enter the trial if they are on 3 mg, and stop budesonide within 14 days of commencement of the trial.
- Patients with Celiac disease or Hashimoto Thyroiditis can be enrolled
- -
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Haemek
Afula
Wolfson Medical Center
Holon
Rabin Medical Center
Petah Tikva
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: Dietary Therapy Using the Crohn's Disease Exclusion Diet (CDED) With Partial Enteral Nutrition or Alone for Induction and Maintenance of Remission in in Adults With Mild to Moderate Crohn's Disease- A Pilot Study
This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks.
Read the detailed description
Environmental factors, the microbiome (bacteria in our gut) and innate immunity all play a role in the pathogenesis of Crohn's disease .Exclusive enteral nutrition (EEN) was found to be effective for inducing remission in active pediatric Crohn's disease, while Partial Enteral Nutrition (PEN) with free diet was not; suggesting that the mechanism of EEN depends on exclusion of dietary components. Dietary factors may play a role in the pathogenesis of the disease, and maybe an important under-investigated therapeutic target.
"The Crohn's Disease Exclusion Diet" (CDED) is a palatable diet excluding components suspected to interfere with the bacteria in our gut or impair immune mechanisms. Our group previously evaluated 47 patients using the Crohn's disease Exclusion Diet + 50% Polymeric formula for 6 weeks, and demonstrated a 78% response rate and 70% disease remission rate using stringent criteria. This was accompanied by a highly significant reduction in markers for inflammation (C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR)), and normalization of CRP in 70% of those entering remission. Among these patients were 13 adults aged 19-32, the remission rate in these 13 patients was 69%, similar to the pediatric data. Importantly, 6/7 patients in this study who refused to drink formula and just used the diet achieved remission, suggesting that the exclusion and not partial enteral nutrition are responsible for the high remission rate. Our former study did not evaluate mucosal healing as an end point, since performing colonoscopies after 6- 12 weeks of therapy is neither ethical nor feasible in children.
At present, data about nutritional therapy and this new dietary approach have been generated primarily in children, and this new diet has not been evaluated for early mucosal healing. The objectives of this pilot study are to generate data in adults, evaluate the diet over a longer period of time (24 weeks) and evaluate mucosal healing. The study is a prospective open label randomized controlled pilot trial in adults, with mild to moderate Crohn's disease who will receive the Crohn's Disease Exclusion Diet (CDED) for 24 weeks.
If effective, this could enable use of a feasible, safe intervention for induction and maintenance of remission as a new therapy or as an adjunctive therapy with medical therapy.
- Conditions
- Crohn's Disease
- Being tested
- Crohns Disease Exclusion Diet + PEN, Crohns Disease Exclusion Diet
- Keywords
- 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.
Crohns Disease Exclusion Diet + PENDietary supplement
Also called CDED + Liquid dietary formula
Patients will use the CDED for a 24 week period, coupled with 1000 m"l of polymeric formula (1 Kcal/m"L) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
Crohns Disease Exclusion DietOther
Also called CDED
Crohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Crohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN Receives: Dietary Supplement: Crohns Disease Exclusion Diet + PEN |
| Group 2 | Experimental | Crohn's Disease Exclusion Diet alone with a calcium supplement Receives: Other: Crohns Disease Exclusion Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission defined as Harvey Bradshaw Index (HBI)<5
Measured: Week 6
Secondary outcomes (4)
Steroid free remission between groups
Measured: Week 6, 12 and 24.
Mucosal healing
Measured: Week 24-26
Changes in mean C-Reactive Protein (CRP)
Measured: Weeks 6, 12 and 24.
Change in mean fecal calprotectin
Measured: Week 6, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 40 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, Wolfson Medical CenterIris Dotan, MD, Principal investigator, Tel Aviv Medical CenterIrit Hermesh, MD, Principal investigator, Rambam Medical Center,Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231814
- Sponsor's protocol ID
- 0105-14
- Acronym
- CDED-AD
- Status last verified
- May 2022
- First submitted
- 27 Aug 2014
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 24983973Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.
PubMed 34739863
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
- Dietary Therapy Using the Crohn's Disease Exclusion Diet (CDED) With Partial Enteral Nutrition or Alone for Induction and Maintenance of Remission in in Adults With Mild to Moderate Crohn's Disease- A Pilot Study
- ClinicalTrials.gov ID
- NCT02231814
- Acronym / sponsor ID
- CDED-AD / 0105-14
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Mild to moderate Crohn's Disease, Diet, Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. Arie LevineOther government
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 4 Sep 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.
This study will evaluate a novel diet for adult crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Half of the patients in this study will receive the CDED alone while the other half will receive the CDED and a liquid diet formula, for 24 weeks.
Detailed description
Environmental factors, the microbiome (bacteria in our gut) and innate immunity all play a role in the pathogenesis of Crohn's disease .Exclusive enteral nutrition (EEN) was found to be effective for inducing remission in active pediatric Crohn's disease, while Partial Enteral Nutrition (PEN) with free diet was not; suggesting that the mechanism of EEN depends on exclusion of dietary components. Dietary factors may play a role in the pathogenesis of the disease, and maybe an important under-investigated therapeutic target.
"The Crohn's Disease Exclusion Diet" (CDED) is a palatable diet excluding components suspected to interfere with the bacteria in our gut or impair immune mechanisms. Our group previously evaluated 47 patients using the Crohn's disease Exclusion Diet + 50% Polymeric formula for 6 weeks, and demonstrated a 78% response rate and 70% disease remission rate using stringent criteria. This was accompanied by a highly significant reduction in markers for inflammation (C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR)), and normalization of CRP in 70% of those entering remission. Among these patients were 13 adults aged 19-32, the remission rate in these 13 patients was 69%, similar to the pediatric data. Importantly, 6/7 patients in this study who refused to drink formula and just used the diet achieved remission, suggesting that the exclusion and not partial enteral nutrition are responsible for the high remission rate. Our former study did not evaluate mucosal healing as an end point, since performing colonoscopies after 6- 12 weeks of therapy is neither ethical nor feasible in children.
At present, data about nutritional therapy and this new dietary approach have been generated primarily in children, and this new diet has not been evaluated for early mucosal healing. The objectives of this pilot study are to generate data in adults, evaluate the diet over a longer period of time (24 weeks) and evaluate mucosal healing. The study is a prospective open label randomized controlled pilot trial in adults, with mild to moderate Crohn's disease who will receive the Crohn's Disease Exclusion Diet (CDED) for 24 weeks.
If effective, this could enable use of a feasible, safe intervention for induction and maintenance of remission as a new therapy or as an adjunctive therapy with medical therapy.
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 | Dietary Supplement: Crohns Disease Exclusion Diet + PENCrohn's Disease Exclusion Diet+Partial Enteral Nutrition (PEN): Crohns Disease Exclusion Diet + PEN |
| Group 2 | Experimental | Other: Crohns Disease Exclusion DietCrohn's Disease Exclusion Diet alone with a calcium supplement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent
- Established Crohn's disease
- Aged 18-55
- Duration of disease up to 5 years
- Harvey Bradshaw Index 5 ≤( HBI) ≤15
Key exclusion criteria (16 listed)
- Patients with severe Disease (HBI > 15) or HBI<5
- Pregnancy,
- Patients with active extraintestinal disease, current B2 (Fixed non inflammatory stricture1 or small bowel obstruction) or B3 disease,
- Patients who used immunomodulator <8 weeks, or had dose changed in past 8 weeks,
- Patients with current or past use of biologics, or use of systemic steroids2,
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 |
|---|---|---|
| Crohns Disease Exclusion Diet + PENAlso: CDED + Liquid dietary formulaPatients will use the CDED for a 24 week period, coupled with 1000 m"l of polymeric formula (1 Kcal/m"L) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase. | Dietary supplement | Group 1 |
| Crohns Disease Exclusion DietAlso: CDEDCrohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase. | Other | Group 2 |
Primary outcome
Clinical remission defined as Harvey Bradshaw Index (HBI)<5
Time frame: Week 6
4 secondary outcomes
Steroid free remission between groups
Time frame: Week 6, 12 and 24.
Mucosal healing
Time frame: Week 24-26
Changes in mean C-Reactive Protein (CRP)
Time frame: Weeks 6, 12 and 24.
Change in mean fecal calprotectin
Time frame: Week 6, 12 and 24
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 34739863Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.
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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.
Arie Levine, MD principal investigator
Wolfson Medical Center
Iris Dotan, MD principal investigator
Tel Aviv Medical Center
Irit Hermesh, MD principal investigator
Rambam Medical Center,Haifa
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crohns Disease Exclusion Diet + PEN and Crohns Disease Exclusion Diet in people with Crohn's Disease, run by Prof. Arie Levine at 4 sites in Israel.
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 7 inclusion and 16 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 4 sites in 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?
Clinical remission defined as Harvey Bradshaw Index (HBI)<5 (time frame: Week 6). 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 NCT02231814, which also lists 2 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.