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New treatment option for Ulcerative Colitis (Disorder)
Official title Effects of Pomegranate Juice on Ulcerative Colitis
ClinicalTrials.gov ID: NCT07115862
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screening
You likely can't join 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...
- Patients with CD, indeterminate/severe to fulminant colitis
- History of colectomy or colonic dysplasia
See the full eligibility 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
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.