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Effects of Pomegranate Juice on Ulcerative Colitis

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will involve 2 phases, each lasting for 8 weeks."
  • "During Phase 2, the intervention group will stop consuming PomJ and switch to consuming their habitual diet, while the delayed start group will consume 237 ml of PomJ daily for 8 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (2)

CA