An Extension Study Testing Experimental "SER-109" in People With Recurrent Clostridium Difficile Infection (a bacteria the colon)

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"This is an Extension Study for ECOSPOR III study. You may qualify if you had a CDI recurrence prior to the week 8 study visit."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Clostridium difficile infection, CDI, infectious diseases
Type: Drug study, Phase 3
Target:
2 Participants
Investigator:
Description
This study is for subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug. Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.

The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI). You may qualify if you are an adult who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.
This study requires

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:

  • Probiotics

  • Loperamide

  • Diphenoxylate/atropine

  • Cholestyramine

  • Opiate treatment unless on a stable dose (Note: short term opiate use is permitted [e.g., for a dental extraction])

  • 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

Who can participate

Inclusion criteria:

  1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of study drug, and have completed their SERES-012 Week 8 visit.
  2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
  3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool test, and assessment by the investigator that the clinical condition of the subject warranted treatment.

Exclusion criteria:

  1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
  2. Known or suspected toxic megacolon and/or known small bowel ileus.
  3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
  4. Absolute neutrophil count of <500 cells/ml3
  5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
  6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
  7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
  8. Any history of fecal microbiota transplantation (FMT)
Benefits and risks of participating
BENEFITS:

If you agree to participate in this study, there may or may not be a direct benefit to you. If you receive the active study drug, another episode of CDI may be prevented but there is no guarantee. Study participants receiving the placebo are not expected to benefit.

RISKS:

As with any investigational treatment, it is not possible to predict all of the unwanted side effects. Your doctor will discuss potential risks with you.
Compensation
If you agree to take part in this research study, we will compensate you $76 for travel expenses for each of the following completed visits: Screening, Day -1, Day 1, Week 1, Week 8, Week 24, Recurrence, ET, Day 2, and Day 3, up to a total of $760.

You may receive additional compensation of $76 if you have any unscheduled CDI recurrence visits.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 27 weeks and will include: Up to 6 study visits at the clinic AND regularly scheduled telephone calls
Recruitment period
From Jan. 17, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Katelyn Conant
Research Topic
Conditions:
  • Clostridium Difficile Infection

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