Pomegranate juice for mild-to-moderate ulcerative colitis

Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study

The goal is to see if drinking 237 ml of pomegranate juice every day for 8 weeks lowers inflammation and changes gut microbes in adults with mild-to-moderate ulcerative colitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT07115862 on ClinicalTrials.gov

What this trial studies

This randomized, controlled 16-week delayed-start trial enrolls adults with mild-to-moderate, biopsy-proven ulcerative colitis and evidence of active inflammation. Participants are randomly assigned to consume 237 ml of pomegranate juice daily for the first 8 weeks while the delayed-start group follows their habitual diet, then the groups switch for the second 8-week phase. Outcomes include fecal calprotectin and partial Mayo score for gut inflammation and quality of life, blood inflammatory and oxidative stress markers, and gut microbiota composition and function (including urolithin metabolites, SCFAs, and bile acids). The delayed-start design provides a control comparison and an exploratory follow-up to see whether any effects persist after stopping juice.

Who should consider this trial

Good fit: Adults (≥18 years) with mild-to-moderate, biopsy-confirmed ulcerative colitis who have supportive evidence of active inflammation, are on stable allowed medications, and follow a low-polyphenol/low-fiber diet are the intended candidates.

Not a fit: Patients with severe ulcerative colitis, unstable or recently changed immunosuppressive therapy, higher-than-allowed steroid doses, or no evidence of active inflammation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, daily pomegranate juice could reduce gut inflammation, improve symptoms and quality of life, and shift the gut microbiota toward a healthier profile.

How similar studies have performed: Preclinical work and small human studies of pomegranate polyphenols suggest anti-inflammatory and microbiome effects, but robust clinical evidence specifically in ulcerative colitis is limited.

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

Where this trial is running

Los Angeles, California and 1 other locations

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

Study contacts

• Principal investigator: Zhaoping Li, MD, PhD — University of California, Los Angeles
• Study coordinator: Tatiana Diacova, PhD, MS, RDN

Conditions Ulcerative Colitis