Crohn DiseaseCD-EDENNCT05606419
The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition for Crohn's Disease
A study testing CDED+PEN and CDED+dairy in people with Crohn Disease, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
This study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Some of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN), while the other group will receive the CDED with early introduction of dairy products, that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- CDED+PEN and CDED+dairy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGreece
- Study dates
- 10 Mar 2024to Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an established diagnosis of CD
- Participants must have clinically active disease defined as HBI ≥ 5
- Participants must have confirmed inflammation at screening as CRP > 5 mg/L, FC >100 mg/g, or presence of inflammation on endoscopy in the 3 months before screening based on retrospective review of procedure reports by the local investigator and the clinician's assessment
- Individuals able to give informed consent and willingness to participate
Who cannot join
- Age < 18 years old
- Previous extensive bowel resection
- Reported pregnancy or lactation
- Current stoma
- Current abscess
- Clinically significant stricture
Show all 10Show fewer
- Introduction of or change in dose of drug therapy within the past 8 weeks
- Comorbidities including diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological, cardiovascular, neoplastic or other autoimmune disease
- Food allergies or intolerances, which do not permit participation in the study
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition (CD-EDEN) in Adult Patients With Crohn's Disease
This study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Some of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN), while the other group will receive the CDED with early introduction of dairy products, that were eliminated from the initial CDED protocol.
Read the detailed description
Crohn's disease (CD) is a chronic relapsing inflammatory bowel disease that has a significant impact on patients' quality of life and is of increased incidence worldwide. The disease aetiology is complex and not fully understood. Accumulated data indicate that environmental factors, including diet, might play a key role in the pathogenesis and inflammation, through mechanisms involving gut dysbiosis, in genetically susceptible people. Epidemiological data suggest that a Mediterranean dietary pattern is associated with decreased risk for CD, whereas a Western diet, rich in animal fat, processed foods and food additives, seems to be linked with an increased disease risk.
Exclusive Enteral Nutrition (EEN) is the only well-established dietary therapy in CD and is used as the first line therapy for the induction of remission in mild to moderate pediatric CD. Evidence according to EEN efficacy in adults is not consistent, which could partly be explained by the compliance difficulty. It is of interest, that feacal inflammation increases rapidly after food re-introduction following EEN in children. Partial enteral nutrition (PEN) has been shown to be beneficial in maintaining remission, but poor compliance due to low formula palatability and patients' fatigue remains an important barrier in the clinical practice. Moreover, PEN is inferior to EEN in inducing remission. Crohn's Disease Exclusion Diet (CDED), which eliminates specific dietary components hypothesized to induce dysbiosis, appears to be effective in inducing and maintaining remission both in pediatric and adult populations. In parallel, patients express a strong interest in ways to manage their disease through diet, so the establishment of a palatable and as flexible as possible dietary pattern, not merely for inducing remission, but also as a feasible maintenance strategy is one of the main priorities in CD research at present.
Therefore, the aim of this study is to explore the effectiveness of the CDED and PEN in both inducing and maintaining remission of CD in adults. The investigators also wish to challenge patients with an early exposure to dairy products, to assess tolerability, prospecting for the development of a more flexible dietary approach based on the CDED principles. The investigators aim to assess the intervention effect on CD activity, based on routinely used clinical indices, blood and faecal inflammatory biomarkers (CRP, FC), health-related quality of life, nutritional status and dietary intake, in patients with mildly active CD.
- Conditions
- Crohn Disease
- Being tested
- CDED+PEN, CDED+dairy
- Keywords
- Inflammatory Bowel Diseases, Diet therapy, Crohn's Disease, Enteral Nutrition, Partial Enteral Nutrition, Gastrointestinal Diseases
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDED+PENDietary supplement
Dietary intervention (Liquid food replacement intervention and specific exclusion diet). Focus on 24 hour diet recalls to asses adherence.
CDED+dairyDietary supplement
Dietary intervention (Specific exclusion diet plus early dairy introduction). Focus on 24 hour diet recalls to asses adherence.
| Study group | Role | What they receive |
|---|---|---|
| CDED + PEN | Experimental | Crohn's Disease Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN): Patients will follow the first phase diet (CDED+50%PEN) for 6 weeks and will continue with CDED phase 2 + 25%PEN for another 6 weeks. Total duration: 12 weeks. Receives: Dietary Supplement: CDED+PEN |
| CDED + Dairy | Active comparator | Crohn's Disease Exclusion Diet (CDED) + dairy products: Patients will follow the first phase diet CDED + 50% of their energy requirements covered by dairy products for 6 week and then will continue with the CDED phase 2 diet + 25% dairy products. Receives: Dietary Supplement: CDED+dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response - Change in Harvey Bradshaw Index (HBI)
Higher HBI scores indicate worse outcomes. Clinical response is defined as baseline HBI score decrease of ≥ 3, and clinical remission is defined as score <5
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (13)
Faecal calprotectin
Change in faecal calprotectin level
Measured: Baseline, 6 weeks, 12 weeks
Change in serum CRP
Abnormal/higher values indicate worse outcomes.
Measured: Baseline, 6 weeks, 12 weeks
Change in serum Albumin
Abnormal values indicate worse outcomes
Measured: Baseline, 6 weeks, 12 weeks
Bowel symptoms improvement
Percent of patients who reported improvement in bowel symptoms, assessed by the validated IBDQ (bowel symptoms domain: 10 questions)
Measured: Baseline, 6 weeks, 12 weeks
Health Related Quality of Life (HR-QoL)
HR-QoL defined by the self-administered Inflammatory Bowel Disease questionnaire (IBDQ) score. Higher IBDQ scores indicate better outcomes. Clinical response defined as increase ≥16 points.
Measured: Baseline, 6 weeks, 12 weeks
Patient's tolerance to the diet
Intolerance: patient's refusal to continue diet (based on reporting and the 24 hour recalls); Adherence will be assessed based on the modified Medication Adherence Report Scale (MARS) questionnaire; The modified MARS questionnaire rates how closely patients adhere to the diet. A score of 1-5 indicates that the patient is not adherent; a score of 6-9 indicates that the patient is adherent.
Measured: Baseline, 6 weeks, 12 weeks
Weight (kg)
Comparison of body weight between the groups.
Measured: Baseline, 6 weeks, 12 weeks
Body mass index (BMI) (kg/m^2)
Comparison of Body Mass Index (BMI) (kg/m2) between the groups.
Measured: Baseline, 6 weeks, 12 weeks
Waist circumference (WC) (cm)
Comparison of WC between groups.
Measured: Baseline, 6 weeks, 12 weeks
Handgrip strength (kg)
Handgrip strength measured with handgrip strength dynamometer
Measured: Baseline, 6 weeks, 12 weeks
Neck circumference (cm)
Comparison of neck circumference measured with tape measure between the groups
Measured: Baseline, 6 weeks, 12 weeks
Mid arm circumference (MAC) (cm)
Measured with tape measure to assess Mid-arm muscle circumference (MAMC) (for estimating FFM, when BIA is not feasible)
Measured: Baseline, 6 weeks, 12 weeks
Triceps Skinfold (TSF) (mm)
Measured with a skinfold caliper to assess Mid-arm muscle circumference (MAMC) for estimating FFM, when BIA in not feasible)
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start10 Mar 2024
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: Study was suspended on September 24 because of funding constraints. At that point, approximately 50 % of the planned participants had enrolled. All data collected to date will be analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Crohn 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with mildly active disease will follow either the CDED diet protocol (CDED + PEN) or the CDED diet with dairy products included, for up to12 weeks. All participants will attend study visits at the beginning, in the middle and at end of the trials, at which points questionnaires will be completed and samples will be collected.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agricultural University of Athens
- Responsible party
- Principal investigator, Dimitrios Karayiannis, Evangelismos Hospital
- Investigators
- Dimitrios Karayiannis, Dr., Principal investigator, Evangelismos General Hospital of AthensKalliopi Anna Poulia, Dr., Study director, Agricultural University of AthensGerasimos Mantzaris, Dr., Study chair, Evangelismos General Hospital of AthensNikos Viazis, Dr., Study chair, Evangelismos General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606419
- Sponsor's protocol ID
- 605/16-12-2021
- Acronym
- CD-EDEN
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gkikas K, Gerasimidis K, Milling S, Ijaz UZ, Hansen R, Russell RK. Dietary Strategies for Maintenance of Clinical Remission in Inflammatory Bowel Diseases: Are We There Yet? Nutrients. 2020 Jul 7;12(7):2018. doi: 10.3390/nu12072018.
PubMed 32645980Levine 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 29777041Bischoff SC, Escher J, Hebuterne X, Klek S, Krznaric Z, Schneider S, Shamir R, Stardelova K, Wierdsma N, Wiskin AE, Forbes A. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clin Nutr. 2020 Mar;39(3):632-653. doi: 10.1016/j.clnu.2019.11.002. Epub 2020 Jan 13.
PubMed 32029281Wall CL, Day AS, Gearry RB. Use of exclusive enteral nutrition in adults with Crohn's disease: a review. World J Gastroenterol. 2013 Nov 21;19(43):7652-60. doi: 10.3748/wjg.v19.i43.7652.
PubMed 24282355Logan M, Clark CM, Ijaz UZ, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, McDonald E, Milling S, Hansen RK, Gerasimidis K, Russell RK. The reduction of faecal calprotectin during exclusive enteral nutrition is lost rapidly after food re-introduction. Aliment Pharmacol Ther. 2019 Sep;50(6):664-674. doi: 10.1111/apt.15425. Epub 2019 Jul 25.
PubMed 31342536Yang H, Feng R, Li T, Xu S, Hao X, Qiu Y, Chen M. Systematic review with meta-analysis of partial enteral nutrition for the maintenance of remission in Crohn's disease. Nutr Res. 2020 Sep;81:7-18. doi: 10.1016/j.nutres.2020.06.006. Epub 2020 Jun 9.
PubMed 32798791Levine 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 31170412Yanai 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Crohn's Disease Exclusion Diet With Early Dairy Introduction vs Partial Enteral Nutrition (CD-EDEN) in Adult Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT05606419
- Acronym / sponsor ID
- CD-EDEN / 605/16-12-2021
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Diseases, Diet therapy, Crohn's Disease, Enteral Nutrition, Partial Enteral Nutrition, Gastrointestinal Diseases
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was suspended on September 24 because of funding constraints. At that point, approximately 50 % of the planned participants had enrolled. All data collected to date will be analyzed.
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Collaborators
- Agricultural University of Athens
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Nov 2022 (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 study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet - CDED). Some of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN), while the other group will receive the CDED with early introduction of dairy products, that were eliminated from the initial CDED protocol.
Detailed description
Crohn's disease (CD) is a chronic relapsing inflammatory bowel disease that has a significant impact on patients' quality of life and is of increased incidence worldwide. The disease aetiology is complex and not fully understood. Accumulated data indicate that environmental factors, including diet, might play a key role in the pathogenesis and inflammation, through mechanisms involving gut dysbiosis, in genetically susceptible people. Epidemiological data suggest that a Mediterranean dietary pattern is associated with decreased risk for CD, whereas a Western diet, rich in animal fat, processed foods and food additives, seems to be linked with an increased disease risk.
Exclusive Enteral Nutrition (EEN) is the only well-established dietary therapy in CD and is used as the first line therapy for the induction of remission in mild to moderate pediatric CD. Evidence according to EEN efficacy in adults is not consistent, which could partly be explained by the compliance difficulty. It is of interest, that feacal inflammation increases rapidly after food re-introduction following EEN in children. Partial enteral nutrition (PEN) has been shown to be beneficial in maintaining remission, but poor compliance due to low formula palatability and patients' fatigue remains an important barrier in the clinical practice. Moreover, PEN is inferior to EEN in inducing remission. Crohn's Disease Exclusion Diet (CDED), which eliminates specific dietary components hypothesized to induce dysbiosis, appears to be effective in inducing and maintaining remission both in pediatric and adult populations. In parallel, patients express a strong interest in ways to manage their disease through diet, so the establishment of a palatable and as flexible as possible dietary pattern, not merely for inducing remission, but also as a feasible maintenance strategy is one of the main priorities in CD research at present.
Therefore, the aim of this study is to explore the effectiveness of the CDED and PEN in both inducing and maintaining remission of CD in adults. The investigators also wish to challenge patients with an early exposure to dairy products, to assess tolerability, prospecting for the development of a more flexible dietary approach based on the CDED principles. The investigators aim to assess the intervention effect on CD activity, based on routinely used clinical indices, blood and faecal inflammatory biomarkers (CRP, FC), health-related quality of life, nutritional status and dietary intake, in patients with mildly active CD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with mildly active disease will follow either the CDED diet protocol (CDED + PEN) or the CDED diet with dairy products included, for up to12 weeks. All participants will attend study visits at the beginning, in the middle and at end of the trials, at which points questionnaires will be completed and samples will be collected.
| Arm | Type | Receives |
|---|---|---|
| CDED + PEN | Experimental | Dietary Supplement: CDED+PENCrohn's Disease Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN): Patients will follow the first phase diet (CDED+50%PEN) for 6 weeks and will continue with CDED phase 2 + 25%PEN for another 6 weeks. Total duration: 12 weeks. |
| CDED + Dairy | Active comparator | Dietary Supplement: CDED+dairyCrohn's Disease Exclusion Diet (CDED) + dairy products: Patients will follow the first phase diet CDED + 50% of their energy requirements covered by dairy products for 6 week and then will continue with the CDED phase 2 diet + 25% dairy products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have an established diagnosis of CD
- Participants must have clinically active disease defined as HBI ≥ 5
- Participants must have confirmed inflammation at screening as CRP > 5 mg/L, FC >100 mg/g, or presence of inflammation on endoscopy in the 3 months before screening based on retrospective review of procedure reports by the local investigator and the clinician's assessment
- Individuals able to give informed consent and willingness to participate
Key exclusion criteria (10 listed)
- Age < 18 years old
- Previous extensive bowel resection
- Reported pregnancy or lactation
- Current stoma
- Current abscess
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 |
|---|---|---|
| CDED+PENDietary intervention (Liquid food replacement intervention and specific exclusion diet). Focus on 24 hour diet recalls to asses adherence. | Dietary supplement | CDED + PEN |
| CDED+dairyDietary intervention (Specific exclusion diet plus early dairy introduction). Focus on 24 hour diet recalls to asses adherence. | Dietary supplement | CDED + Dairy |
Primary outcome
Clinical response - Change in Harvey Bradshaw Index (HBI)
Time frame: Baseline, 6 weeks, 12 weeks
Higher HBI scores indicate worse outcomes. Clinical response is defined as baseline HBI score decrease of ≥ 3, and clinical remission is defined as score <5
13 secondary outcomes
Faecal calprotectin
Time frame: Baseline, 6 weeks, 12 weeks
Change in serum CRP
Time frame: Baseline, 6 weeks, 12 weeks
Change in serum Albumin
Time frame: Baseline, 6 weeks, 12 weeks
Bowel symptoms improvement
Time frame: Baseline, 6 weeks, 12 weeks
Health Related Quality of Life (HR-QoL)
Time frame: Baseline, 6 weeks, 12 weeks
Patient's tolerance to the diet
Time frame: Baseline, 6 weeks, 12 weeks
Weight (kg)
Time frame: Baseline, 6 weeks, 12 weeks
Body mass index (BMI) (kg/m^2)
Time frame: Baseline, 6 weeks, 12 weeks
Waist circumference (WC) (cm)
Time frame: Baseline, 6 weeks, 12 weeks
Handgrip strength (kg)
Time frame: Baseline, 6 weeks, 12 weeks
Neck circumference (cm)
Time frame: Baseline, 6 weeks, 12 weeks
Mid arm circumference (MAC) (cm)
Time frame: Baseline, 6 weeks, 12 weeks
Triceps Skinfold (TSF) (mm)
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 32645980Gkikas K, Gerasimidis K, Milling S, Ijaz UZ, Hansen R, Russell RK. Dietary Strategies for Maintenance of Clinical Remission in Inflammatory Bowel Diseases: Are We There Yet? Nutrients. 2020 Jul 7;12(7):2018. doi: 10.3390/nu12072018.
- 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.
- Background: PubMed 32029281Bischoff SC, Escher J, Hebuterne X, Klek S, Krznaric Z, Schneider S, Shamir R, Stardelova K, Wierdsma N, Wiskin AE, Forbes A. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clin Nutr. 2020 Mar;39(3):632-653. doi: 10.1016/j.clnu.2019.11.002. Epub 2020 Jan 13.
- Background: PubMed 24282355Wall CL, Day AS, Gearry RB. Use of exclusive enteral nutrition in adults with Crohn's disease: a review. World J Gastroenterol. 2013 Nov 21;19(43):7652-60. doi: 10.3748/wjg.v19.i43.7652.
- Background: PubMed 31342536Logan M, Clark CM, Ijaz UZ, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, McDonald E, Milling S, Hansen RK, Gerasimidis K, Russell RK. The reduction of faecal calprotectin during exclusive enteral nutrition is lost rapidly after food re-introduction. Aliment Pharmacol Ther. 2019 Sep;50(6):664-674. doi: 10.1111/apt.15425. Epub 2019 Jul 25.
- Background: PubMed 32798791Yang H, Feng R, Li T, Xu S, Hao X, Qiu Y, Chen M. Systematic review with meta-analysis of partial enteral nutrition for the maintenance of remission in Crohn's disease. Nutr Res. 2020 Sep;81:7-18. doi: 10.1016/j.nutres.2020.06.006. Epub 2020 Jun 9.
- 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 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.
- 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.
Dimitrios Karayiannis, Dr. principal investigator
Evangelismos General Hospital of Athens
Kalliopi Anna Poulia, Dr. study director
Agricultural University of Athens
Gerasimos Mantzaris, Dr. study chair
Evangelismos General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDED+PEN and CDED+dairy in people with Crohn Disease, run by Evangelismos Hospital at 1 site in Greece.
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 4 inclusion and 10 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: paused, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Results are not available in the source record.
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 response - Change in Harvey Bradshaw Index (HBI) (time frame: Baseline, 6 weeks, 12 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 NCT05606419, which also lists 8 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 30 Sep 2025.