The Crohn's Disease Exclusion Diet With Early Dairy Introduction Plus Partial Enteral Nutrition for Crohn's Disease

Study Purpose

This study aims to evaluate a novel diet for adult Crohn's disease patients (The Crohn's Disease Exclusion Diet

- CDED) plus partial enteral nutrition.

Half of the patients in this study will receive the CDED combined with partial enteral nutrition (PEN) and the other half will receive PEN along with the usual nutritional care. Moreover, the investigators wish to challenge patients in remission with a low dose exposure to dairy products, that were eliminated from the CDED, to examine if that exposure is well tolerated.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants must have an established diagnosis of CD.

- Individuals able to give informed consent and willingness to participate.

Exclusion Criteria:

- Age < 18 years old.

- Previous extensive bowel resection.

- Reported pregnancy or lactation.

- Current stoma.

- Current stenosis or abscess.

- Clinically significant stricture.

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05606419
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Evangelismos Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dimitrios Karayiannis, Dr.Kalliopi Anna Poulia, Dr.Gerasimos Mantzaris, Dr.
Principal Investigator Affiliation	Evangelismos General Hospital of AthensAgricultural University of AthensEvangelismos General Hospital of Athens
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease

Additional Details

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 in remission with a low dose exposure to dairy products, to assess tolerability, prospecting for the development of a personalized remission maintenance diet 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 or inactive CD.

Arms & Interventions

Arms

Experimental: Group 1-Remission

Crohn's Disease Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN)+dairy products: Patients with asymptomatic disease will follow the first stage diet (CDED+50%PEN) for 4 weeks and will continue with CDED + 25%PEN + dairy products for another 4 weeks. Total duration: 8 weeks.

Active Comparator: Group 2 - Remission

Partial Enteral Nutrition (PEN) + usual nutritional care: Patients with asymptomatic disease will be given PEN plus the usual advice for a healthy dietary pattern. PEN will cover the 50% of total energy requirements for the first 4 weeks. During the second 4 weeks, PEN will cover the 25% of the total energy requirements.Total duration: 8 weeks

Experimental: Group 1 - Active Disease

Crohn's Disease Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN)+dairy products: Patients with active disease will follow the first stage diet (CDED + 50%PEN) for 6 week and then, the responders will continue with adding the advised dairy products for 4 more weeks (CDED+25%PEN+dairy products).

Active Comparator: Group 2 - Active Disease

Partial Enteral Nutrition (PEN) + usual nutritional care: Patients with symptomatic disease will be given PEN plus the usual advice for a low residue diet. PEN will cover the 50% of total energy requirements for the first 6 weeks. During the next 4 weeks, PEN will cover the 25% of the total energy requirements.Total duration: 10 weeks

Interventions

Dietary Supplement: - CDED+PEN+dairy products

Dietary intervention (Liquid food replacement intervention and specific exclusion diet with gradual re-introduction of dairy products). Focus on 24 hour diet recalls to asses adherence.

Dietary Supplement: - PEN+usual care

Liquid food replacement intervention and regular diet. Focus on 24 hour diet recalls and FFQ to asses dietary habits.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Konstantina Morogianni, MSc

konstantina.morogianni@gmail.com

+30 2132045035

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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