Dr. Dan W. Pulsipher, of Access Healthcare, is involved with an exciting ECOSPOR III research study for adult patients who have a documented history of three or more episodes of Clostridium difficile infection (recurrent CDI) in the previous nine months. This is a study using an innovative investigational Ecobiotic® drug that helps to reduce recurrent infection by repairing the ecology of the microbiome community.
The leading risk factor for CDI is a prior history of taking antibiotics, which decrease the diversity of the microbiome making the patient vulnerable to infection with the spores of C. difficile. Although targeted antibiotics against Clostridium difficile kill the toxin-producing vegetative forms, one out of four patients with primary CDI do not sustain a durable clinical response because:
o Antibiotics do not kill the dormant spores
o Repeat exposure to antibiotics exacerbate the dysbiotic microbiome, which fosters spore germination and recurrence
o Furthermore, the risk of recurrence is estimated at approximately 60% among those patients with multiple recurrences
In the ECOSPOR study, doctors are evaluating the investigational medication SER-109. SER-109 expedites the race to repair the microbiome before C. difficile spore germination can lead to recurrence. Based on a prior Phase 2 clinical trial results, higher doses have been selected for the Phase 3 clinical trial to optimize microbiome kinetics and compositional changes associated with protection against recurrence. Previous studies in subjects with recurrent CDI suggest that SER-109 is safe and well-tolerated; the main adverse events are gastrointestinal in nature.
Eligible patients in the double-blind ECOSPOR study will be randomized in a 1:1 ratio to receive either an oral dose of SER-109 (in four capsules) once daily for 3 days or matching placebo. This study involves 8 weeks of efficacy observation and 16 weeks of long-term safety follow up, where patients will either come into the clinic or be contacted by phone and asked about adverse events and diarrheal symptoms.
To pre-qualify for the study, patients must:
• Be 18 years of age or above
• Have a documented history of 3 or more episodes of CDI within the previous 9 months, inclusive of the current episode
• Currently experiencing a CDI recurrence
Patients who experience a recurrence of CDI up to 8 weeks following treatment will have the opportunity to enroll in an open-label SER-109 treatment study.
All study-related visits, tests, and medications will be provided at no cost. Reimbursement for study-related time and travel may also be available.
Access Health Care Physicians, LLC main office is located at 5350 Spring Hill Drive, Spring Hill, Florida 34606. For more information on the research call 352-364-9401 or go to www.ahcpllc.net