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

Korábbi kezelés

• Highly variable dosing of anti-inflammatory medications (dose changes more than 1x per week)
• Currently receiving intravenous nutrition support therapy (or 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
• Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening

Más betegség

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

Laborértékek

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

Egyéb

• 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.
• 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 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

• 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