Phase
Condition
Gastrointestinal Diseases And Disorders
Ulcers
Treatment
PEN+usual care
CDED+PEN
CDED+dairy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 >100mg/g, or presence of inflammation on endoscopy in the 3 months before screeningbased on retrospective review of procedure reports by the local investigator and theclinician's assessment
Individuals able to give informed consent and willingness to participate
Exclusion
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 seriouscomorbidity 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 forparasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
Study Design
Study Description
Connect with a study center
Evangelismos General Hospital of Athens
Athens, Attica 10676
GreeceSite Not Available
Evangelismos General Hospital of Athens
Athens 264371, Attica 6692632 10676
GreeceSite Not Available

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