Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
habitual diet -> pomegranate juice
pomegranate juice -> habitual diet
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
• Adults ≥ 18 yo
Following a low-polyphenol and fiber diet (< 3 servings of fruits/vegetablesper day)
Mild-to-moderate UC at the time of screening (2 ≤ partial Mayo scores ≤ 5)
Supportive evidence of active inflammation (hsCRP >1 mg/L, fecal calprotectin >50 µg/g stool, or abnormal lower endoscopy) in individuals with biopsy-provenUC
Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior toscreening
Patients on treatment with immunosuppressive therapy (e.g.,azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeksprior to baseline visit
At the time of baseline visit, patients may be on no more than 20 mg/day ofprednisone and 9 mg/day of budesonide MMX
Subjects must read and sign the Institutional Review Board-approved writteninformed consent prior to the initiation of any study specific procedures orenrollment. A subject will be excluded for any condition that might compromisethe ability to give truly informed consent.
Exclusion
Exclusion Criteria:
• Non-English speaker
Vegetarian/vegan
Known pomegranate allergy
Documented chronic disease besides UC, including diabetes, renal or liverdiseases, metabolic syndrome, active cancer, MI or stroke, history of gastricbypass
Patients with CD, indeterminate/severe to fulminant colitis
History of colectomy or colonic dysplasia
Presence of ileal pouch or ostomy
Evidence of active bacterial or viral gastroenteritis as indicated by positivestool studies for ova & parasites, Clostridium difficile, and stool culture
Recent hospitalizations (within 2 weeks of screening) for UC requiring IVsteroids
Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl
Recent systemic antibiotics use (within 3 months of screening) or active use ofanti-diarrheal medications
Taking supplements known to affect metabolism or gut microbiota composition (probiotics, fiber, etc.), unless willing to stop for the study duration
Use of Total Parenteral Nutrition (TPN)
Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior toscreening
Taking exogenous hormones (e.g., hormone replacement therapy)
Recent weight fluctuations (>10% in the last 6 months)
Smoker or living with a smoker
Use of >20 g of alcohol per day
Unable or unwilling to comply with the study protocol (including unwillingnessto avoid watermelon and other lycopene-rich foods for the whole duration of thestudy)
Unable to provide consent
Study Design
Study Description
Connect with a study center
UCLA Center for Human Nutrition
Los Angeles, California 90095
United StatesSite Not Available
West Los Angeles VA Medical Center
Los Angeles, California 90073
United StatesSite Not Available
UCLA Center for Human Nutrition
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
West Los Angeles VA Medical Center
Los Angeles 5368361, California 5332921 90073
United StatesSite Not Available

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