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Not Yet Recruiting NCT05606419

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

Conditions: Crohn Disease

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Evangelismos Hospital

Summary

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.

Eligibility Criteria

Inclusion Criteria:Participants must have an established diagnosis of CDIndividuals able to give informed consent and willingness to participateExclusion Criteria:Age < 18 years oldPrevious extensive bowel resectionReported pregnancy or lactationCurrent stomaCurrent stenosis or abscessClinically significant strictureIntroduction of or change in dose of drug therapy within the past 8 weeksComorbidities including diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological, cardiovascular, neoplastic or other autoimmune diseaseFood allergies or intolerances, which do not permit participation in the studyAny 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05606419). StuddyBuddy aggregates publicly available trial information.