Cranberry supplement for gut health in Crohn's disease
Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
EARLY_PHASE1 · University of Massachusetts, Worcester · NCT07170462
This trial will test whether taking a daily cranberry supplement for 10 weeks can improve gut bacteria, lower inflammation, and help adults with Crohn's disease feel better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester (other) |
| Drugs / interventions | natalizumab, ustekinumab, vedolizumab, methotrexate, prednisone |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT07170462 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled early phase 1 trial where adults with Crohn's disease are assigned 1:1 to a freeze-dried cranberry powder supplement or matching placebo daily for 10 weeks. Participants provide blood, urine, and stool samples and complete online questionnaires at four time points over a 15-week period to track microbiome changes, inflammation, symptoms, and quality of life. The primary outcome is change in gut microbiome composition, with secondary outcomes including inflammatory markers, gastrointestinal symptoms, and persistence of any microbiome shifts after stopping the supplement. The trial enrolls adults 18–65 with confirmed Crohn's disease and impaired health-related quality of life who can adhere to daily supplement use and specimen collection.
Who should consider this trial
Good fit: Adults aged 18–65 with confirmed Crohn's disease, sCDAI <450, sIBDQ <60, stable medication doses, able to take a daily supplement and provide required samples, and residing in Massachusetts are ideal candidates.
Not a fit: Patients with an ostomy, recent symptomatic strictures or obstruction, pregnancy, or who cannot comply with daily supplement use or specimen collection are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the cranberry supplement could shift gut microbiome composition and reduce inflammation, potentially improving symptoms and quality of life for some patients.
How similar studies have performed: Preclinical studies and small human trials suggest cranberry polyphenols and fermentable fiber can have prebiotic-like effects, but larger randomized trials in Crohn's disease are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Worcester, Massachusetts
- UMASS medical center — Worcester, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Ana Maldonado-Contreras, PhD — University of Massachusetts, Worcester
- Study coordinator: Madeline Johns
- Email: MadelineNunez.Johns@umassmed.edu
- Phone: 508-856-5279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, cranberry, dietary supplement, crohn disease