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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
UMASS medical center
RECRUITING
Worcester
Contact Information
Primary
Madeline Johns
MadelineNunez.Johns@umassmed.edu
508-856-5279
Time Frame
Start Date: 2025-10-29
Estimated Completion Date: 2026-09-15
Participants
Target number of participants: 50
Treatments
Experimental: Cranberry
Participants in the intervention arm will be provided with 7 servings of Cranberry whole powder per week. Participants in the intervention arm are expected to consume 1 serving per day of cranberry whole powder for 10 weeks.
Placebo_comparator: Placebo
Participants in the placebo arm will be provided with 7 servings of placebo powder (placebo supplement matched in appearance and flavor) per week. Participants in the placebo arm are expected to consume a serving per day of placebo powder for 10 weeks.
Related Therapeutic Areas
Sponsors
Leads: Ana Maldonado-Contreras

This content was sourced from clinicaltrials.gov