Effects of Pomegranate Juice on Ulcerative Colitis

Recruiting now · Not applicable

Conditions studied: Ulcerative Colitis (Disorder)

In brief

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)

Key facts

Study ID

NCT07115862

Run by

University of California, Los Angeles

People needed

30

Starts

2025-10-15

Expected to finish

2027-10-15

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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

Where it is running

• UCLA Center for Human Nutrition — Los Angeles, California, United States (enrolling)
• West Los Angeles VA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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