Cranberry and Gut Health in Crohn's Disease

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAna Maldonado-Contreras

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cranberry powder
  • Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ana Maldonado-Contreras

Lead sponsor

University of Massachusetts, Worcester

Sponsor institution