NCT07170462CompletedEarly phase 1
Cranberry and Gut Health in Crohn's Disease
Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 17 Jul 2025
- Start date
- 29 Oct 2025
- Primary completion date
- 15 Aug 2026
- Lead sponsor
- Ana Maldonado-Contreras
- Diseases
- Crohn's disease
- NCT number
- NCT07170462
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 31
- From 29 Oct 2025 to the primary completion date, 15 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
Other
- Ostomy
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMASS medical center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.