Actively Recruiting
Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
Led by Ana Maldonado-Contreras · Updated on 2025-11-20
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can improve gut health in adults with Crohn's disease. Crohn's disease is a chronic inflammatory bowel condition linked with an imbalance in gut bacteria, often leading to reduced quality of life. This randomized, double-blind, placebo-controlled trial aims to study the effect of daily cranberry powder intake on the gut microbiome, inflammation, and health-related quality of life in those with Crohn's disease. Participants will be randomly assigned to one of two groups: one group will take a cranberry whole powder supplement once daily for 10 weeks, while the other group will take a placebo powder that looks and tastes similar. The study lasts a total of 15 weeks, including the 10-week intervention and a 4-week follow-up phase. Supplements are pre-packaged to keep participants and researchers unaware of group assignments. During the study, participants will complete questionnaires and collect blood, urine, and stool samples at four times: before starting, at week 6, at the end of 10 weeks, and after the follow-up at week 14. These assessments include measuring Crohn's disease activity, symptoms, quality of life, diet, and inflammation markers. Participants will also track any medication changes or side effects daily. Biological samples will be analyzed to understand changes in gut bacteria and related health markers.
CONDITIONS
Brief Title
Cranberry and Gut Health in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult Crohn's disease patients aged between 18 and 65 years
- Women of childbearing potential must use at least one form of highly effective contraception during the study
- Confirmed diagnosis of Crohn's disease
- Crohn's disease activity lower than sCDAI <450
- Moderate to severely impaired health-related quality of life with sIBDQ score less than 60
- Stable medication dose at screening for specified drugs within defined time frames
- Willingness and ability to consume cranberry supplement daily
- Able to comply with specimen collection and study procedures
- Able to provide written informed consent
- Reside in Massachusetts, USA
You will not qualify if you...
- Presence of an ostomy
- Symptomatic or significant stricture or history of obstruction within past 6 months
- Pregnancy
- Use of Specific Carbohydrate Diet or IBD-AID within 4 weeks of screening
- Use of probiotics within 4 weeks of screening
- Use of antibiotics within 4 weeks of screening
- Use of more than 20mg prednisone or equivalent
- Recent Clostridioides difficile colitis
- Unable to provide informed consent personally
- Prisoners
- Children under 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 weeks
Participants consume a daily cranberry powder supplement or placebo for 10 consecutive weeks to evaluate effects on the gut microbiome, inflammation, and quality of life.
4 home collection and assessment time points at baseline, week 6, week 10, and week 14 using home kits and questionnaires
Duration - 4 weeks
Participants complete a 4-week follow-up period after stopping the supplement to assess persistence of microbiome changes and other outcomes.
Trial Site Locations
Total: 1 location
1
UMASS medical center
Worcester, Massachusetts, United States, 10655
Actively Recruiting
Research Team
M
Madeline Johns
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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