Cranberry and Gut Health in Crohn's Disease

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Crohn Disease (CD), Crohn Disease

In brief

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.

Key facts

Study ID

NCT07170462

Run by

Ana Maldonado-Contreras

People needed

50

Starts

2025-10-29

Expected to finish

2026-08-15

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UMASS medical center — Worcester, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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