Natural Product Signature in Adults with Crohn’s Disease
To assess the safety of, as well as how a natural product derived from the Hops plant is broken down by the bacteria in the intestines of adults with Crohn’s disease.
· Men and women 21-50 years of age
· Have active Crohn's disease [not in remission based on Crohn's Disease Activity Index (CDAI)]
· Willing to take placebo or an experimental natural product for 8 weeks
· Willing to have blood drawn every two weeks and fast for 10-12 hours before blood draws
· Willing and able to collect every two weeks 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
· Able to provide written informed consent
· Non-smoker (including tobacco and Cannabis products, combusted or vaporized)
· Have made dosing changes in anti-inflammatory medications (i.e., Tylenol, aspirin, ibuprofen, naproxen, and/or other prescriptions) more than 1x per week
· Are currently or recently (within last 14 days) taking any dietary supplements containing flavonoids or “anti-inflammatory” ingredients including: curcumin, turmeric, fenugreek, hops, rosemary, ginger, white willow, devil's claw, fish oil (doses>1g/day), quercetin, or compounds from the above.
· Are currently receiving intravenous nutrition support therapy (or within the last 14 days)
· Are currently taking anti-coagulant or anti-platelet prescription medications (or they were taken within the last 14 days)
· Are currently taking antibiotic, antiparasitic, or antifungal medications orally or intravenously (or they were taken within the last 14 days)
· Have initiated or made changes to supplements or medications within 14 days prior to screening
· Have initiated or made changes to an exercise regimen within 14 days prior to screening
· Have initiated or made changes to a food plan within 14 days prior to screening
· Are currently involved in or within 14 days prior to screening initiated 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)
Study participants will take one capsule of the study product once per day for 8 weeks, and attend 6 in-person study visits, including a screening visit, baseline visit and 4 bi-weekly clinical visits. Participants will complete questionnaires about their quality of life, general symptoms, and digestive and bowel disease symptoms, including an abdominal examination conducted by a physician. Participants will also have their blood drawn at each visit and asked to collect a stool sample and a 24-hour urine sample at home before each visit using kits provided.
Description of treatment or intervention (mechanism of action):
We are studying a natural product derived from the Hops plant that has antioxidant and anti-inflammatory properties. This product has been shown to be beneficial to gut bacteria and may help reduce gut inflammation, increase the absorption of bile acids, and reduce gut permeability.
Patient participation requirements:
Participants may receive up to $1000 compensation for participating in this study
· Participant requirements include:
- Completing a telephone and in-person screening visit to determine eligibility
- If eligible, attend 6 in-person visits over an 8-week period
- Sign a consent form to join the study
- Complete a W9 form to process compensation payment
- Complete a Release of Medical Records form to determine the status and history of their Crohn's disease.
- Be willing to be randomized to a treatment and placebo group
- Take a study supplement capsule (containing either the study product mixed in a rice-protein base or a placebo) once a day for 8 weeks.
- Answer questions about their digestive and bowel disease symptoms
- Undergo an abdominal exam by the physician on site
- Complete questionnaires about their quality of life and any adverse events
- Provide a list of medications and supplements
- Have their vitals measured (weight, height, waist circumference, blood pressure, heart-rate, temperature)
- Provide a fasting blood sample
- Provide a stool sample (collected at home prior to the visit from a kit provided)
- Collect a 24-hour urine sample (using a container provided)
Possible risks and side effects:
There are no known toxicities for human taking oral supplements with a natural hops product. Most people are exposed to this natural hops product through the consumption of beer. Based on previous studies on humans and animals, we expect that study participants will not develop adverse effects from taking the study product for 8 weeks.
Risks associated with any dietary supplement include gastrointestinal symptoms such as gas, bloating, digestive upset and change in bowel movement frequency or consistency. Also, there is a chance of identifying a previously unknown allergy, and therefore a risk of rash, breathing difficulty and serious allergic reaction.
There will be six blood draws during this study. There is a small chance that the needle will cause some discomfort, bruising, redness or bleeding at the needle puncture site. Some people may feel lightheaded or faint during or immediately after a blood sample is collected. There is a rare risk of swelling around the vein or of infection.
We will do everything we can to ensure that records are kept private, yet there is always a small risk of a breach of confidentiality of personal health information. These risks have been addressed and minimized as much as is possible by keeping data in locked cabinets and on password protected and encrypted computers, and by using ID numbers instead of names on all data collected.
There is a chance that some participants may confuse research study visits for routine clinical care. We would like to emphasize that all study visits are for research purposes only and not for medical care.
There could be risks that we are unaware of at the time of the study. Participants will be notified of any new information that may affect their willingness to participate in the study.
Progress to date:
We recently completed a Phase 1 study of this natural hops product among healthy adults. No participants discontinued from the study due to adverse events. Blood tests found no adverse changes and were within normal laboratory reference ranges at all time points. All adverse events were non-serious and most were related to preexisting symptoms.