RECRUITINGEarly Phase 1INTERVENTIONAL

Cranberry and Gut Health in Crohn's Disease

Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 significantly consume the cranberry supplement daily. - Willing and able to comply with specimen collection and other study procedures, and to complete the study. - Able to provide written willing to sign a consent form. - Reside in Massachusetts, USA. Who Should NOT Join This Trial: - Ostomy - Presence of symptomatic or significant stricture or history of obstruction in the past 6 months - Pregnancy - Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening - Use of probiotics within 4 weeks of screening - Use of antibiotics within 4 weeks of screening - \> 20mg prednisone or equivalent - Recent C. difficile colitis - Unable to provide willing to sign a consent form for themselves - Prisoners - Children Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 significantly consume the cranberry supplement daily. * Willing and able to comply with specimen collection and other study procedures, and to complete the study. * Able to provide written informed consent. * Reside in Massachusetts, USA. Exclusion Criteria: * Ostomy * Presence of symptomatic or significant stricture or history of obstruction in the past 6 months * Pregnancy * Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening * Use of probiotics within 4 weeks of screening * Use of antibiotics within 4 weeks of screening * \> 20mg prednisone or equivalent * Recent C. difficile colitis * Unable to provide informed consent for themselves * Prisoners * Children

Treatments Being Tested

DRUG

Cranberry powder

Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.

DIETARY_SUPPLEMENT

Placebo

placebo powder (9 g powder, no (poly)phenols, no fibers

Locations (1)

UMASS medical center

Worcester, Massachusetts, United States