NCT04590508

A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A pilot study to assess the safety and tolerability of an orally administered natural product derived from hops, called xanthohumol, in humans with Crohn's Disease, in order to identify a biological signature of xanthohumol exposure, and to characterize the role of xanthohumol metabolism by intestinal microorganisms in that signature within adults with Crohn's Disease.

Detailed description

This is a double-masked, placebo controlled, randomized clinical trial of xanthohumol, which is a constituent of hops (Humulus lupulus). Hops and its constituents have a long history of use for a variety of conditions. However, knowledge is limited regarding the measurable biological markers of human exposure, and the role of xanthohumol metabolism by microorganisms present in the gut, particularly in individuals with gut pathologies such as Crohn's Disease. This information is necessary for the development of xanthohumol as a potential therapeutic intervention in such conditions.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Xanthohumol	The xanthohumol supplement will be administered in a capsule and taken orally.
OTHER	Placebo	The placebo will be administered in a capsule and taken orally.

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-08-22
• Completion: 2025-07-30
• First posted: 2020-10-19
• Last updated: 2024-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study