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Polyphenol
Xanthohumol for Crohn's Disease (XMaS Trial)
Phase 2
Waitlist Available
Led By Ryan Bradley, ND/MPH
Research Sponsored by National University of Natural Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For individuals of child-bearing potential, willingness to use an intrauterine device (IUD) or two other concurrent forms of birth control (e.g., 2 of the following categories: condoms, spermicide-containing gels, films or sponges; and/or vaginal rings) to prevent pregnancy while enrolled
Adults aged 21-50
Must not have
Highly variable dosing of anti-inflammatory medications (dose changes more than 1x per week)
Use of inhaled or ingested Cannabis products, including Cannabidiol (CBD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 4 weeks, 6 weeks, and 8 weeks
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed but generally include any unexpected reactions to xanthohumol as a natural product. These could range from mild digestive discomfort to allergic reactions; however, part of the study aims to assess overall tolerability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to use an IUD or two other forms of birth control during the study.
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I am between 21 and 50 years old.
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My Crohn's disease is active and not in remission.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My anti-inflammatory medication dose changes frequently.
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I use inhaled or ingested cannabis products, including CBD.
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I have not been hospitalized in the last 3 months, except for planned medical procedures.
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I am not pregnant, breastfeeding, or planning to become pregnant soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks, 4 weeks, 6 weeks, and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 4 weeks, 6 weeks, and 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline: Aspartate aminotransferase (AST)
Change from Baseline: Blood urea nitrogen to creatinine ratio
Complete Blood Count
+3 moreSecondary study objectives
Change from Baseline: Change in fecal calprotectin levels
Change from Baseline: Change in plasma inflammatory markers (pg/mL)
Change from Baseline: Composite Symptoms: Crohn's Disease Activity Index (CDAI)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: XanthohumolExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Participants will receive capsules filled with a rice protein vehicle by mouth once daily with the first daily meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanthohumol
Not yet FDA approved
Find a Location
Who is running the clinical trial?
National University of Natural MedicineLead Sponsor
31 Previous Clinical Trials
1,259 Total Patients Enrolled
Oregon State UniversityOTHER
50 Previous Clinical Trials
8,414 Total Patients Enrolled
Pacific Northwest National LaboratoryFED
9 Previous Clinical Trials
3,744 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I use inhaled or ingested cannabis products, including CBD.I have not used illegal drugs like cocaine or meth in the last 14 days.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.I have not taken supplements like turmeric or fish oil in the last 14 days.My Crohn's disease is active and not in remission.I am currently on blood thinners or have taken them in the last 14 days.I have been on IV nutrition recently.I am currently on or recently took antibiotics, antiparasitics, or antifungals.I haven't started or changed any medications or supplements in the last 2 weeks.I have not been hospitalized in the last 3 months, except for planned medical procedures.I have not had any gastrointestinal surgery in the last 3 months.I haven't had cancer in the last 5 years, except for skin or early cervical cancer.I am not pregnant, breastfeeding, or planning to become pregnant soon.I am willing to fast for 10-12 hours and have blood drawn every two weeks.You smoke or use any form of nicotine products (such as cigarettes or e-cigarettes).You drink more than one beer every day.You do not smoke, including tobacco and cannabis products that are either burned or heated.
Research Study Groups:
This trial has the following groups:- Group 1: Xanthohumol
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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