|Age:||18 years or older|
|Keywords:||Clostridium difficile infection, CDI, infectious diseases|
|Type:||Drug study, Phase 3|
If you decide to participate, you will be assigned by chance (like the flipping of a coin), to receive one of two study treatments: Study Drug (SER-109) or a placebo. You will have a 1 out of 2 chance, or a 50% chance of receiving the Study Drug. This study is double-blinded, which means that neither you nor your study doctor or the study staff will know which study drug you are receiving. However, the study drug you receive will be made known in the case of an emergency.
If you are assigned to receive the Study Drug, you will receive single daily doses of 3×107 spore colony forming units (SCFU) in 4 capsules administered orally (by mouth) each day for 3 consecutive days. If you are assigned to receive placebo, you will receive matching placebo containing no active drug in 4 capsules administered by mouth each day for 3 consecutive days.
You will be instructed to take all study drug doses in the morning after an overnight fast of 8 or more hours (nothing by mouth except for small amounts of water). You will need to remain fasting for up to 60 minutes after you take the study drug. You must come to the clinic or have a home visit on Day 2 and Day 3 to witness you taking the study drug.
If you take part in this research, you will be expected to:
Come to all of your study visits and follow the instructions given to you by the study doctor and study staff
Let your study doctor know of any changes in your health while you are in this study
Check with your study doctor before starting to take any new medications or remedies
Not take part in any other research studies while you are taking part in this study
Notify your study doctor immediately if you or your partner becomes pregnant
Notify your study doctor immediately if you choose to stop your participation in the study for any reason, so that a plan can be made for your continued medical care
Return to the clinic for your final study visit, as described above Please do not give blood for non-study purposes, unless medically required, while you are taking part in this study. The following drugs/therapies are prohibited for the duration of the study:
Opiate treatment unless on a stable dose (Note: Short term opiate use is permitted (e.g., for a dental extraction).
Chemotherapy, radiotherapy, or biologic treatment for active malignancy
Oral Fidaxomicin, oral metronidazole, oral vancomycin, used to treat for anything else other than CDI recurrences
Fecal Microbiota Transplantation (FMT) prior to CDI recurrence in the study
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.