Xanthohumol for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Crohn's DiseaseXanthohumol - Drug
Eligibility
21 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial investigates whether a natural product derived from hops is safe and tolerable for people with Crohn's Disease, and whether it produces a biological signature in these patients.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: 2 weeks, 4 weeks, 6 weeks, and 8 weeks

Week 8
Change from Baseline: Aspartate aminotransferase (AST)
Change from Baseline: Blood urea nitrogen to creatinine ratio
Change from Baseline: Change in fecal calprotectin levels
Change from Baseline: Change in plasma inflammatory markers (pg/mL)
Complete Blood Count
Change from Baseline: Composite Symptoms: Crohn's Disease Activity Index (CDAI)
Change from Baseline: Estimated glomerular filtration rate
Change from Baseline: gamma-Glutamyl transferase (GGT)
Change from Baseline:Alanine aminotransferase (ALT)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Xanthohumol
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

32 Total Participants · 2 Treatment Groups

Primary Treatment: Xanthohumol · Has Placebo Group · Phase 2

Xanthohumol
Drug
Experimental Group · 1 Intervention: Xanthohumol · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanthohumol
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks, 4 weeks, 6 weeks, and 8 weeks

Who is running the clinical trial?

National University of Natural MedicineLead Sponsor
27 Previous Clinical Trials
1,255 Total Patients Enrolled
Oregon State UniversityOTHER
44 Previous Clinical Trials
8,333 Total Patients Enrolled
Pacific Northwest National LaboratoryFED
9 Previous Clinical Trials
3,744 Total Patients Enrolled

Eligibility Criteria

Age 21 - 50 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to collect a 24-hour urine sample before each study visit.
You are of child-bearing potential and willing to use an IUD or two other forms of birth control to prevent pregnancy while enrolled.
You are willing to take isolated Xanthohumol as a dietary supplement for 8 weeks.
You are willing to have blood drawn bi-weekly and fast for 10-12 hours before blood draws.
You are willing and able to collect bi-weekly stool samples at home.