Xanthohumol for Crohn's Disease

(XMaS Trial)

Overseen By John Phipps, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National University of Natural Medicine

Must not be taking: Anticoagulants, Antibiotics, Antifungals, others

Disqualifiers: Malignancy, Gastrointestinal surgery, Smoking, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your medication doses frequently and that you have not started or changed any medications or supplements within 14 days before screening. If you are taking certain anti-inflammatory supplements or medications, you may need to stop them for 14 days before joining the study.

How does the drug Xanthohumol differ from other treatments for Crohn's Disease?

Xanthohumol is unique because it is a natural compound derived from hops with anti-inflammatory properties, and it works by inhibiting specific inflammatory pathways (like the NF-κB signaling pathway) that are not typically targeted by standard Crohn's Disease treatments. This makes it a novel option for potentially reducing inflammation and altering gut microbiota in patients with Crohn's Disease. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ryan Bradley, ND/MPH

Principal Investigator

National University of Natural Medicine

Eligibility Criteria

Adults aged 21-50 with active Crohn's Disease (CDAI score >150) who are non-smokers, willing to fast before blood draws, collect stool and urine samples bi-weekly, and use reliable contraception if of child-bearing potential. Excluded are those on certain medications or diets recently, hospitalized or had GI surgery within the last 3 months, pregnant women, heavy drinkers/smokers, or using illicit drugs.

Inclusion Criteria

I am willing to use an IUD or two other forms of birth control during the study.

I am between 21 and 50 years old.

I am willing to take a dietary supplement for 8 weeks.

Exclusion Criteria

My anti-inflammatory medication dose changes frequently.

You started a new exercise routine or changed your existing one within 2 weeks before screening.

You have changed your diet within two weeks before screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive xanthohumol or placebo capsules daily for 8 weeks

8 weeks

4 visits (in-person) at 2-week intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Xanthohumol

Trial Overview The trial is testing xanthohumol's safety and effects in adults with Crohn's Disease. Participants will take an oral supplement derived from hops for 8 weeks while their biological response is monitored through blood tests, stool samples, and urine collection to understand how gut microbes metabolize it.

Participant Groups

Group I: Xanthohumol Experimental Treatment 1 Intervention

Participants will take capsules containing 24 mg of xanthohumol in a rice protein vehicle by mouth once daily with the first daily meal.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal.

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Oregon State University

Collaborator

Trials

51

Recruited

8,300+

Pacific Northwest National Laboratory

Collaborator

Trials

10

Recruited

3,800+

References

1. England pubmed.ncbi.nlm.nih.gov

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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Xanthohumol prevents dextran sulfate sodium-induced colitis via inhibition of IKKβ/NF-κB signaling in mice. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Xanthohumol suppresses inflammatory response to warm ischemia-reperfusion induced liver injury. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Protective effect of xanthohumol on toxin-induced liver inflammation and fibrosis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Neuroprotective effects of xanthohumol, a prenylated flavonoid from hops (Humulus lupulus), in ischemic stroke of rats. [2012]