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Status:

RECRUITING

Cranberry and Gut Health in Crohn's Disease

Lead Sponsor:

Ana Maldonado-Contreras

Conditions:

Crohn Disease (CD)

Crohn Disease

Eligibility:

All Genders

18-65 years

Phase:

EARLY_PHASE1

Brief 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 h...

Detailed Description

This randomized, double-blind, placebo-controlled clinical trial evaluates the effect of a cranberry dietary supplement-rich in polyphenols and fermentable fiber-on the gut microbiome, inflammation, a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 29 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 15 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07170462

Start Date

October 29 2025

End Date

September 15 2026

Last Update

November 20 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UMASS medical center

Worcester, Massachusetts, United States, 10655