Summary:
Current medications for UC rely on suppressing the body's immune system. For some people, this approach may bring unwanted side effects or may not work well enough to treat symptoms. The ECO-RESET Study will look at an all-natural, non-pharma investigational medication that is designed to work differently, and which it is hoped will provide a new way to treat UC. Studies have shown that people with UC often have changes in the population of bacteria living in their intestines (guts), called the gut microbiome. The investigational medication contains purified bacteria from healthy individuals' stool (feces). Researchers hope that adding good bacteria will help restore the health of the gut microbiome in individuals with UC. This investigstional medication has already been given to a select population with mild-to-moderate UC; this previous study demonstrated that the investigational medication had few side effects, reduced patients' UC symptoms, and improved the appearance of the intestines.
Qualified Participants Must:
• Qualified participants must be 18-80 years of age
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Have been diagnosed with mild-to-moderate UC for at least 3 months
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Have already tried at least 1 UC medication that was not effective
Qualified Participants May Receive:
Participants in the ECO-RESET Study will receive either the investigational medication or placebo, all as capsules taken by mouth once daily. Your chance of getting placebo is only 1 in 3. If your UC has improved, you will go into the maintenance period, taking either the investigational medication or placebo once a week. Following a UC flare-up during the induction period or the maintenance period, you will be eligible for transfer to the open-label extension period (in which you will receive the active medication). Participation in the study will last for up to 67 weeks and will include between 11 and 14 visits to the study center, and up to 7 follow-up telephone calls.
Study visits encompass a variety of free tests and assessements including: physical examinations (e.g. measuring weight and height), vital signs measurements (blood pressure and pulse rate), blood, urine, and stool tests to check general health, and lower endoscopies and biopsies.