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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a natural product called xanthohumol, derived from hops, to determine its safety and tolerability for people with Crohn's Disease. Researchers aim to understand how xanthohumol interacts with the body, particularly its processing by gut bacteria. The trial includes two groups: one taking xanthohumol and the other a placebo (a pill with no active ingredient). Adults with active Crohn's Disease who are not in remission and are non-smokers are suitable candidates for this study. Participants will take capsules daily and provide blood, stool, and urine samples throughout the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that xanthohumol is likely to be safe for humans?

Research has shown that xanthohumol, a natural substance found in hops, is generally safe for people. In one study, healthy adults took 24 mg of xanthohumol daily for eight weeks without major problems. The treatment was well-tolerated, with no serious side effects reported. Another study found similar results, confirming the safety of this dose for people with Crohn's Disease. Although the FDA has not yet approved xanthohumol as a medicine, it is available as a dietary supplement, indicating its safety for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for Crohn's disease, which typically include medications like corticosteroids, immunosuppressants, and biologics to reduce inflammation and suppress the immune system, Xanthohumol offers a unique approach. This compound, derived from hops, is gaining attention for its potential anti-inflammatory and antioxidant properties. Researchers are excited about Xanthohumol because it might provide a more natural treatment option with fewer side effects. Additionally, its novel mechanism could target inflammation in a more targeted way, potentially improving patient outcomes.

What evidence suggests that xanthohumol might be an effective treatment for Crohn's Disease?

Research has shown that xanthohumol, a substance from hops, reduces inflammation. This finding is promising for treating Crohn's Disease, which causes swelling in the digestive tract. In this trial, participants will receive either xanthohumol or a placebo. Studies indicate that xanthohumol can influence gut bacteria, potentially improving gut health. Early findings suggest it is safe and well-tolerated in healthy adults. While more research is needed, these initial results offer hope for people with Crohn's Disease. ^{1 2 3 4 5}

Who Is on the Research Team?

Ryan Bradley, ND/MPH

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9587656/

Xanthohumol microbiome and signature in adults with ... Xanthohumol (XN), a bioactive flavonoid from Humulus lupulus with anti-inflammatory properties, has potential benefits for patients with Crohn's ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04769-2

Xanthohumol microbiome and signature in healthy adults (the ... The tertiary aim is to collect preliminary data related to effects on gut permeability, xanthohumol metabolism, and impact on the gut microbiome ...

3. withpower.com withpower.com/trial/phase-3-crohn-disease-9-2020-dca86

Xanthohumol for Crohn's Disease (XMaS Trial) 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 ...

4. osti.gov osti.gov/pages/biblio/2469848

a protocol for a phase II triple-masked, placebo-controlled ... Xanthohumol (XN), a bioactive flavonoid from Humulus lupulus with anti-inflammatory properties, has potential benefits for patients with Crohn's disease ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8221389/

Xanthohumol Microbiome and Signature in Healthy Adults ... Conclusion. Over an eight-week period, 24 mg daily xanthohumol was safe and well-tolerated by healthy adults.