The Cranberry Study
The goal of this study is to find out if taking a cranberry supplement (which contains natural plant compounds called polyphenols, a group of naturally occurring plant compounds that have antioxidant and anti-inflammatory properties and fiber can help improve gut health in people with Crohn’s disease.
Who Can Join This Study?
- Adults between 18 and 65 years old who have been diagnosed with active Crohn’s disease (measured by a score called sCDAI under 450.)
- Patients with poor quality of life due to Crohn’s disease (measure by a score called sIBDQ under 60.)
- Patients with stable medications for Crohn’s:
- Thiopurines, natalizumab, or methotrexate: used for at least 12 weeks.
- Anti-TNF medications, ustekinumab, or vedolizumab: used for at least 8 weeks.
- 5-ASA: used for at least 2 weeks.
- Steroids: stable dose for at least 1 week.
- Patients willing and able to take a cranberry supplement daily as part of the study.
- Patients willing and able to follow study instructions, provide samples, and complete all study activities which includes:
- Patients who can read and sign a consent form agreeing to join the study.
- Patients must live in Massachusetts, USA.
Who Cannot Join This Study?
- Patients with a stoma (ostomy).
- Patients who have a blocked or narrowed part of the intestine causing symptoms or had a blockage in the last 6 months.
- Patients who are pregnant.
- Patients who have followed a Specific Carbohydrate Diet or IBD-AID diet in the last 4 weeks.
- Patients who have taken probiotics or antibiotics in the last 4 weeks.
- Patients taking more than 20 mg of prednisone (or similar steroid).
- Patients who have had a recent infection with C. difficile (a type of bacteria that causes diarrhea).
- Patients who are incarcerated.
Timeline: This is a 15 weeks and is broken into three parts:
- Baseline period (1 week): This is the starting point, where we collect initial information before the intervention starts.
- Intervention period (10 weeks): Patients will be asked to take a daily dose of the cranberry supplement.
- Follow-up period (4 weeks): After the intervention period ends, we will continue to check on your health.
Study Activities-In each study period we will monitor:
- Changes in your gut bacteria by collecting stool samples.
- Inflammatory markers in patient’s blood,
- Cranberry intake in patients’ urine.
- Disease activity, quality of life, and dietary intake using online surveys.