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

Launched by EVANGELISMOS HOSPITAL · Nov 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new diet called the Crohn's Disease Exclusion Diet (CDED) for adults with Crohn's disease, a condition that causes inflammation in the digestive tract. The study will compare different diet plans: one group will follow the CDED along with a special nutrition supplement called partial enteral nutrition (PEN), another group will have PEN with standard nutritional care, and the third group will follow the CDED but can introduce dairy products earlier than usual. The goal is to see how these different diets help manage Crohn's disease symptoms.

To be eligible, participants need to have a confirmed diagnosis of Crohn's disease and be experiencing active symptoms, such as inflammation. Participants must be at least 18 years old and able to give their consent to join the study. However, those with certain medical conditions or complications, like recent surgery or specific infections, won’t be able to participate. If you join the study, you can expect regular check-ups and support from the research team as you follow one of the dietary plans. This trial could offer valuable insights into better ways to manage Crohn's disease through diet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Age \< 18 years old
• • Previous extensive bowel resection
• • Reported pregnancy or lactation
• • Current stoma
• • Current 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.