Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study
The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will: 1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life 2. affect the microbes living in the gut (gut microbiota)
• • 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.