Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
Ana Maldonado-Contreras
Summary
This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria. In this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients). All participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health. Participation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.
Description
This randomized, double-blind, placebo-controlled clinical trial evaluates the effect of a cranberry dietary supplement-rich in polyphenols and fermentable fiber-on the gut microbiome, inflammation, and health-related quality of life in adults with Crohn's disease (CD). Crohn's disease is a chronic inflammatory bowel disease associated with significant dysbiosis (disruption of the gut microbial community), and patients often experience impaired quality of life despite medical treatment. There is growing interest in food-based strategies that may favorably impact the gut microbiota in individua…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult CD patients between 18 and 65 years old. * Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study. * Confirmed diagnosis of Crohn's disease. * CD activity lower than sCDAI\<450. * Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score \<60. * Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks), * steroids (1 week). * Willingness and capacity to significa…
Interventions
- DrugCranberry powder
Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.
- Dietary SupplementPlacebo
placebo powder (9 g powder, no (poly)phenols, no fibers
Location
- UMASS medical centerWorcester, Massachusetts