Effects of Pomegranate Juice on Ulcerative Colitis

Laborértékek

• • Non-English speaker
  • Vegetarian/vegan
  • Known pomegranate allergy
  • Documented chronic disease besides UC, including diabetes, renal or liver diseases, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass
  • 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 positive stool studies for ova \& parasites, Clostridium difficile, and stool culture
  • Recent hospitalizations (within 2 weeks of screening) for UC requiring IV steroids
  • 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 of anti-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 to screening
  • 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 unwillingness to avoid watermelon and other lycopene-rich foods for the whole duration of the study)
  • Unable to provide consent

• • Adults ≥ 18 yo
  • Following a low-polyphenol and fiber diet (< 3 servings of fruits/vegetables per 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-proven UC
  • Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screening
  • Patients on treatment with immunosuppressive therapy (e.g., azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeks prior to baseline visit
  • At the time of baseline visit, patients may be on no more than 20 mg/day of prednisone and 9 mg/day of budesonide MMX
  • Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.