UCRecruiting

Effects of Pomegranate Juice on Ulcerative Colitis

Not applicable · Testing pomegranate juice -> habitual diet and habitual diet -> pomegranate juice · 2 sites · University of California, Los Angeles

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing pomegranate juice -> habitual diet and habitual diet -> pomegranate juice as supportive care (to help with symptoms or quality of life). Condition(s) listed: Ulcerative Colitis (Disorder).

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

• 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)

Plus 5 more requirement(s). There are also 20 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 30 participants are expected to take part.
Start date: 2025-10-15.
Main results expected around 2027-10-15 (estimate from the record).
2 study sites listed (1 marked recruiting) in United States.

Main thing being measured

simple clinical colitis activity index (SCCAI) (At baseline, 8 weeks and 16 weeks)

In the researchers’ words

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)

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Ulcerative Colitis (Disorder)
Lead sponsor	University of California, Los Angeles
Collaborators	National Institutes of Health (NIH); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment	30 (estimated)
Start date	2025-10-15
Primary completion (est.)	2027-10-15
First posted	2025-08-11
Last updated	2025-12-09
Official title	Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study
ClinicalTrials.gov ID	NCT07115862

Interventions

pomegranate juice -> habitual diet (Other)
237 ml of pomegranate juice for the first 8 weeks -> habitual diet for the second 8 weeks
habitual diet -> pomegranate juice (Other)
habitual diet for the first 8 weeks -> 237 ml of pomegranate juice for the second 8 weeks

Full eligibility criteria (from the record)

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

Locations (2)

Site	City	Country	Site status
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

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.