Seres C-Diff Study

Is another Clostridioides difficle infection getting in the way of your life?

Consider this medical research study of an investigational medication that may help prevent these infections from recurring.

When you or someone you care about has a Clostridioides difficile infection (CDI), the effects can be difficult to handle. Every day, a person can experience diarrhea that is frequent , out of control, and worst of all, can begin without any warning.

For adults who live with recurrent CDI, doctors and researchers are conducting the ECOSPOR IV medical research study. In this study, investigators want to evaluate the safety and effectiveness of an investigational medication to see if it helps reduce recurrences of CDI. All eligible patients will receive treatment with SER 109, the investigational medication.

The leading risk factor for Clostridioides difficile infection (CDI) is a prior history of taking antibiotics. Exposure to antibiotics can kill the good bacteria in the gut that make up our microbiome. These beneficial bacteria protect us from harmful invaders, like C. difficile , which can cause diarrhea. Although antibiotics can treat the symptoms of CDI , many patients go on to have recurrences because their microbiome has not recovered.

SER-109 is an investigational medication designed to reduce recurrences after antibiotics. SER-109 will be administered to all subjects in ECOSPOR IV. The results of the trial will provide more information about the potential safety and effectiveness of SER-109. By taking part in this study, you will be making an important contribution to CDI research.

Rather than killing C. diff bacteria, like antibiotics do, SER-109 is designed to replenish the gut bacteria which research indicates are protective against C. diff in the healthy human gut. The bacterial spores included in SER-109 germinate in the gut and compete for the same nutrients that C. diff spores need to germinate. They also make chemicals that inhibit C. diff spores from germinating. Therefore, when delivered after antibiotic treatment, SER-109 may reduce C. diff recurrence. SER-109 bacterial spores come from the stool of healthy donors and are aimed at returning the gut bacteria to its healthy state.

In order to qualify for the study, your answers to the following must be YES:

  • Be 18 years of age or older
  • Now experiencing 3 or more unformed bowel movements per day over two consecutive days (potential current C. diff infection)
  • Have had a C. diff infection in the past year
  • Have been told by your physician you may have to take antibiotics

What can I expect if I enroll in the study?

If you enroll in the study, you are guaranteed to receive the active study drug, SER-109. You will have a minimum of 2 clinic visits and up to 12 telephone visits over 24 weeks. At one of your clinic visits you will be given 4 capsules of SER-109 which are taken orally (by mouth). Over the subsequent 2 days you will take an additional 4 capsules of SER-109 each day. All treatment and visits will be provided at no cost to you. You may also be entitled to reimbursement for your time and travel costs.

All study related visits, tests, and medication will be provided to participants at no cost.

Reimbursement for time and travel may be provided.

If you qualify and are interested in partaking in this study, please fill out the following: