Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT07170462

Cranberry and Gut Health in Crohn's Disease

Led by Ana Maldonado-Contreras · Updated on 2025-11-20

50

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Cranberry and Gut Health in Crohn's Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Women of childbearing potential must use highly effective contraception during the study
  • Confirmed diagnosis of Crohn's disease
  • Crohn's disease activity index (sCDAI) less than 450
  • Moderate to severely impaired health-related quality of life (sIBDQ score less than 60)
  • Stable medication doses as specified (thiopurines, natalizumab, methotrexate for 12 weeks; anti-TNF, ustekinumab, vedolizumab for 8 weeks; 5-ASA for 2 weeks; steroids for 1 week)
  • Willingness and ability to consume the cranberry supplement daily
  • Ability and willingness to comply with specimen collection and study procedures
  • Able to provide written informed consent
  • Reside in Massachusetts, USA
Not Eligible

You will not qualify if you...

  • Presence of ostomy
  • Symptomatic or significant bowel stricture or history of obstruction in past 6 months
  • Pregnancy
  • Use of Specific Carbohydrate Diet or IBD-AID within 4 weeks before screening
  • Use of probiotics within 4 weeks before screening
  • Use of antibiotics within 4 weeks before screening
  • Use of more than 20 mg prednisone or equivalent
  • Recent Clostridium difficile colitis
  • Unable to provide informed consent
  • Prisoners
  • Children under 18 years

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UMASS medical center

Worcester, Massachusetts, United States, 10655

Actively Recruiting

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Research Team

M

Madeline Johns

CONTACT

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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