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

NCT04590508 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-18

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

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.

Sponsors & Collaborators

  • Oregon State University

    collaborator OTHER

  • Pacific Northwest National Laboratory

    collaborator FED

  • National University of Natural Medicine

    lead OTHER

Principal Investigators

  • Ryan Bradley, ND/MPH · National University of Natural Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-08-22
Completion
2025-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590508 on ClinicalTrials.gov