NCT07170462 · Ana Maldonado-Contreras
Cranberry and Gut Health in Crohn's Disease
What this study is about
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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
- 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
Where
- Worcester, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations