Clinical Trial 46696

Sun City West, AZ 85375


Summary:

 

ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile infection (RCDI)

The purpose of this study is to see how safe and tolerable SER-109 is in keeping Clostridioides difficile infection (CDI) from coming back in people who have recovered from at least a first recurrence of CDI.

Clostridioides difficile, also called “C. diff,” is a type of bacteria that is present in the environment, and in a small percentage of healthy people, can be present in low amounts as part of the bacteria in the intestine or colon. Patients with a history of antibiotic use may develop CDI. Antibiotics can reduce the amount of normal healthy bacteria found in the large intestine or colon, which allows for the growth of C. diff bacteria leading to CDI. C. diff bacteria makes a toxin, or poison, which causes diarrhea that can be very mild and last a few days, or may be severe causing frequent diarrhea, abdominal pain, and may even require life- saving surgery. After recovering from CDI, it is not uncommon for the infection to come back in weeks, months or years later in some people. This is called recurrent CDI and is a significant medical condition for many people.

 

 


Qualified Participants Must:

• Be age 18 and older
• Currently experiencing a C.Diff infection or have symptoms that you think may be a C.Diff recurrence
• Had at least one C.Diff occurrence anytime in the past
• Be willing to discontinue use of probiotics for the duration of the study (up to 27 weeks)
• Not have undergone intestinal surgery within the past 3 months or have a history of total colectomy, gastric bypass, lap band surgery or any weight loss surgeries


Qualified Participants May Receive:

Study related care at no cost, study medication, compensation for time and travel 


Available At:

Clinical Research Institute of Arizona, LLC
14506 W Granite Valley Dr. Suite 214
Sun City West, AZ 85375
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.