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Search / Trial NCT07115862

Effects of Pomegranate Juice on Ulcerative Colitis

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Aug 4, 2025

Trial Information

Current as of August 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether drinking one cup (237 ml) of pomegranate juice every day for 8 weeks can help people with ulcerative colitis (a condition that causes inflammation in the colon). Researchers want to see if the juice can reduce inflammation both in the gut and throughout the body, improve quality of life, and change the types of bacteria living in the gut.

Adults with mild to moderate ulcerative colitis who eat a diet low in certain plant compounds and fiber might be eligible. Participants must have signs of active inflammation and be on stable medication doses for their condition. During the study, they will need to drink pomegranate juice daily and avoid certain foods like watermelon. People with other serious health issues, allergies to pomegranate, or who smoke won’t qualify. The study is not yet recruiting, but if you join, expect to follow a specific diet and medication plan while researchers track your health and gut bacteria over the two months.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 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.
  • Exclusion Criteria:
  • • 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

About University Of California, Los Angeles

The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.

Locations

Los Angeles, California, United States

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Zhaoping Li, MD, PhD

Principal Investigator

University of California, Los Angeles

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported