Crohn DiseaseNCT06324513
Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease.
A study testing Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) and Crohn's disease exclusion diet (CDED) in people with Crohn Disease, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
Trial summary
The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) and Crohn's disease exclusion diet (CDED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesItaly
- Study dates
- 27 Jul 2023to 27 Oct 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a stable diagnosis of Crohn's disease according to the criteria of the ECCO/ESPGHAN guidelines.
- Patients with a new diagnosis of the disease or with a disease diagnosed no more than three years ago, receiving stable pharmacological therapy for at least 2 months with immunomodulators (thiopurines, methotrexate, azathioprine) or biologic drugs who have experienced a disease relapse and require reinduction of remission.
- Mild to moderate disease activity assessed by the wPCDAI score between 12.5-57.5 in the pediatric population and a Harvey-Bradshaw Index ranging from 5 to 16 for the adult population.
- Biochemical evidence of active intestinal inflammation at enrollment, assessed by inflammatory markers such as C-reactive protein (CRP) levels ≥ 0.5 mg/dl or fecal calprotectin ≥ 150 mg/g.
- Ability to provide biological samples (stool and blood samples).
Who cannot join
- Monogenic disease;
- Disease with fibrostenotic or penetrating phenotype;
- Complex perianal fistulizing disease not completely in remission;
- Patients with ileostomy or who have undergone intestinal resection or colectomy;
- Patients currently undergoing other nutritional therapy (e.g., exclusive enteral nutrition) or who have undergone it in the last month;
- Patients not on stable therapy with immunomodulators or biologic drugs or who started therapy with thiopurines less than 4 weeks before enrollment, or methotrexate less than 8 weeks before enrollment;
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- Patients with recent use of systemic steroids in the four weeks before enrollment or recent initiation or dose adjustment phase of therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) or biologic drugs;
- Pregnancy;
- Vegan or vegetarian patients;
- Celiac disease.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Paolo Lionetti, paolo.lionetti@meyer.it
- Recruiting
Ospedali Riuniti Villa Sofia-Cervello
Palermo
Ambrogio Orlando, ambrogiorlando@gmail.com
- Recruiting
Università La Sapienza di Roma
Roma
Salvatore Oliva, salvatore.oliva@uniroma1.it
About this study
Official title: Adaptation of the Mediterranean Diet Pattern to the Exclusion Diet for Crohn's Disease: Assessment of Efficacy and Tolerability in Pediatric and Adult Patients. Non-profit, Multicenter, Randomized, Controlled Study.
The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.
These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.
Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy.
- Conditions
- Crohn Disease
- Being tested
- Mediterranean Crohn's Disease Exclusion Diet (Med-CDED), Crohn's disease exclusion diet (CDED)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)Dietary supplement
The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks.
Crohn's disease exclusion diet (CDED)Dietary supplement
The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease.
| Study group | Role | What they receive |
|---|---|---|
| Med-CDED | Experimental | The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks. Receives: Dietary Supplement: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) |
| CDED | Active comparator | The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease Receives: Dietary Supplement: Crohn's disease exclusion diet (CDED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to the first phase of diet
reduction of 12.5 points in the wPCDAI score.
Measured: 8 weeks
Clinical remission rate
wPCDAI score must be <12.5 points after the first phase of diet
Measured: 8 weeks
Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort
Adherence rate will be assessed by adherence questionnaire score or by considering the number of patients who refuse the diet
Measured: Anytime during the study
Clinical remission rate in adult patients at the end of phase I of diet
Clinical remission will be assessed by HBI < 5 points
Measured: 8 weeks
Secondary outcomes (9)
Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort
The thickness of intestinal loops will be assess by using ultrasound
Measured: 0, 8, 24, 38 and 52 weeks
Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort
ESR, CPR and fecal calprotectin will be measured at the end of phase I of the diet
Measured: 8 weeks
Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort
Assessment of clinical remission rate at Phase II of both diet protocols
Measured: 24 weeks
Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort
Assessment of clinical remission rate at Phase III of both diet protocols
Measured: 52 weeks
Endoscopic response rate obtained at 6 months both in pediatric and adult cohort
The assessment will be performed in a subgroup of partecipants that will recive endoscopy at baseline and after 6 months
Measured: 0 and 26 weeks
Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
Bioinformatic analysis of the composition of the intestinal microbiota will be performed after extraction of bacterial genomic DNA from the collected faecal samples and NGS sequencing with the Illumina MiSeq platform. These analyses will allow taxonomic identification of theintestinal microbial communities in each patient. Indices of microbial richness and biodiversity (Chao index, Shannon and Simpson index) will be calculated, and principal coordinate (PCoA) and multidimensional (NMDS) analyses will be performed to assess variability in microbial composition between the various phases of the dietary intervention.
Measured: 52 weeks
Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
faecal metabolome will be carried out by gas chromatography and mass spectrometry analysis. The identification of differentially abundant metabolites will be carried out by comparing profiles at various stages of the dietary intervention.
Measured: 52 weeks
Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
Transcriptome investigation of blood samples, gene expression profiles of the individual's RNA, will be identified by NGS sequencing techniques. Transcriptomic analysis will be performed in R using the DESeq2 package
Measured: 52 weeks
Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived
Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment recived assessed with nutritional questionnair
Measured: Anytime during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start27 Jul 2023
- Primary completion27 Jul 2025 (estimated)
- Study completion27 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Lionetti, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324513
- Sponsor's protocol ID
- Med-CDED
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Mediterranean Diet Pattern to the Exclusion Diet for Crohn's Disease: Assessment of Efficacy and Tolerability in Pediatric and Adult Patients. Non-profit, Multicenter, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT06324513
- Acronym / sponsor ID
- Med-CDED
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 27 Jul 2025 (estimated)
- Study completion
- 27 Oct 2025 (estimated)
- First posted
- 22 Mar 2024 (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.
The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.
These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.
Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Med-CDED | Experimental | Dietary Supplement: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks. |
| CDED | Active comparator | Dietary Supplement: Crohn's disease exclusion diet (CDED)The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a stable diagnosis of Crohn's disease according to the criteria of the ECCO/ESPGHAN guidelines.
- Patients with a new diagnosis of the disease or with a disease diagnosed no more than three years ago, receiving stable pharmacological therapy for at least 2 months with immunomodulators (thiopurines, methotrexate, azathioprine) or biologic drugs who have experienced a disease relapse and require reinduction of remission.
- Mild to moderate disease activity assessed by the wPCDAI score between 12.5-57.5 in the pediatric population and a Harvey-Bradshaw Index ranging from 5 to 16 for the adult population.
- Biochemical evidence of active intestinal inflammation at enrollment, assessed by inflammatory markers such as C-reactive protein (CRP) levels ≥ 0.5 mg/dl or fecal calprotectin ≥ 150 mg/g.
- Ability to provide biological samples (stool and blood samples).
Key exclusion criteria (10 listed)
- Monogenic disease;
- Disease with fibrostenotic or penetrating phenotype;
- Complex perianal fistulizing disease not completely in remission;
- Patients with ileostomy or who have undergone intestinal resection or colectomy;
- Patients currently undergoing other nutritional therapy (e.g., exclusive enteral nutrition) or who have undergone it in the last month;
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 |
|---|---|---|
| Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks. | Dietary supplement | Med-CDED |
| Crohn's disease exclusion diet (CDED)The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease. | Dietary supplement | CDED |
Primary outcome
Clinical response to the first phase of diet
Time frame: 8 weeks
reduction of 12.5 points in the wPCDAI score.
Clinical remission rate
Time frame: 8 weeks
wPCDAI score must be <12.5 points after the first phase of diet
Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort
Time frame: Anytime during the study
Adherence rate will be assessed by adherence questionnaire score or by considering the number of patients who refuse the diet
Clinical remission rate in adult patients at the end of phase I of diet
Time frame: 8 weeks
Clinical remission will be assessed by HBI < 5 points
9 secondary outcomes
Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort
Time frame: 0, 8, 24, 38 and 52 weeks
Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort
Time frame: 8 weeks
Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort
Time frame: 24 weeks
Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort
Time frame: 52 weeks
Endoscopic response rate obtained at 6 months both in pediatric and adult cohort
Time frame: 0 and 26 weeks
Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
Time frame: 52 weeks
Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
Time frame: 52 weeks
Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort
Time frame: 52 weeks
Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived
Time frame: Anytime during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) and Crohn's disease exclusion diet (CDED) in people with Crohn Disease, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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 Italy. 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?
Contact Paolo Lionetti, MD (3398416059, paolo.lionetti@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to the first phase of diet (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2024.