drugset / Trial / NCT04590508
A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease
Phase 2
Active not recruiting
20 enrolled
National University of Natural Medicine
Oregon State University · collabPacific Northwest National Laboratory · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2020-10-01
- Primary completion
- 2024-08-22
- Completion
- 2025-07-30
Publications
- Jamieson PE, Gu I, Reichart NJ, Maier CS, Ho E, Sharpton TJ, Metz TO, Bradley R, Stevens JF. Modulation of Microbiota-Derived Bile Acids Linked to Symptom Amelioration in Crohn's Disease: Insights From a Randomized Clinical Trial With Xanthohumol Supplementation. Mol Nutr Food Res. 2026 May;70(10):e70501. doi: 10.1002/mnfr.70501.
- Bradley R, A Staab C, E Jamieson P, O Langley B, O Metz T, F Stevens J. Safety and Tolerability of Xanthohumol in Adults With Crohn's Disease: Results of a Triple-Masked, Randomized, Placebo-Controlled Phase 2 Trial. Mol Nutr Food Res. 2026 Mar;70(6):e70438. doi: 10.1002/mnfr.70438.
- Langley BO, Ryan JJ, Phipps J, Buttolph L, Bray B, Aslan JE, Metz TO, Stevens JF, Bradley R. Xanthohumol microbiome and signature in adults with Crohn's disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial. Trials. 2022 Oct 22;23(1):885. doi: 10.1186/s13063-022-06782-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xanthohumol | Small molecule | 24 mg | Oral |