A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University of Natural Medicine
• Collaborators: Oregon State University; Pacific Northwest National Laboratory
• Treatments: Xanthohumol

Criteria

Inclusion Criteria:

• Adults 21-50 years of age

• Active Crohn's disease not in remission based on a CDAI score >150

• Willing to take isolated Xanthohumol as a dietary supplement for 8 weeks

• Willing to have blood drawn bi-weekly and fast for 10-12 hours before blood draws

• Willing and able to collect bi-weekly stool samples at home

• Willing and able to collect a 24-hour urine sample before each study visit

• Able to speak, read and understand English

• Must be able to provide written informed consent

• Non-smokers (including tobacco and Cannabis products, combusted or vaporized)

• 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

Exclusion Criteria:

• Highly variable dosing of anti-inflammatory medications (dose changes more than 1x per week)

• Currently or recent (within last 14 days) taking any dietary supplements containing xanthohumol, flavonoids, or other known "anti-inflammatories" including: curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, devil's claw, fish oil (doses>1 g/day), or quercetin. Candidates will be given the option to "wash out" for 14 days and re-contact the study team.

• Consumption of more than 1 beer per day.

• Currently receiving intravenous nutrition support therapy (or within the last 14 days)

• Currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 14 days)

• Currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 14 days)

• Initiation of or changes to supplements or medications within 14 days prior to screening.

• Initiation of or changes to an exercise regimen within 14 days prior to screening.

• Initiation of or changes to a food plan within 14 days prior to screening.

• Current involvement or within 14 days prior to screening of a significant diet or weight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast, and/or HMR)

• Hospitalization (for any reason other than a scheduled medical procedure) within 3 months prior to screening

• Gastrointestinal surgery within 3 months prior to screening

• Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)

• Women who are lactating, pregnant or planning pregnancy within the next four months

• Typical intake of more than 2 alcohol-containing beverages per day, more than 14 per week, or more than 4 in any single day within the past 14 days.

• Smoking tobacco or nicotine products (combusted or vaporized)

• Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening

• Use of inhaled or ingested Cannabis products, including Cannabidiol (CBD)

• Currently participating in another interventional research study, or participated in another interventional research study within 14 days of screening

• Do not have an active primary care provider or specialist (i.e., gastroenterologist) managing their CD