Cranberry and Gut Health in Crohn's Disease (NCT07170462) | Clinical Trial Compass
RecruitingEarly Phase 1
Cranberry and Gut Health in Crohn's Disease
United States50 participantsStarted 2025-10-29
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling