Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  C.diff
• Age: Between 18 years - 150 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Have successfully completed a full course of a standard of care CDI antibiotic (see definition of ‘Clinical Cure’) for a qualifying CDI episode (p
  2. Prior to the first dose of study drug, completion of standard of care antibiotic therapy with oral vancomycin, metronidazole, or fidaxomicin for CDI with a treatment duration of 10 to 21 days
  3. Clinical cure assessed and confirmed at screening and reconfirmed at Day 1 visit (randomization)
  4. Subject is able to begin treatment with study drug within 3 to 7 days following completion (i.e., last dose) of the CDI antibiotic course for the qualifying CDI episode
  5. For female subjects of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive approved and deemed highly effective by the United States Food and Drug Administration through 30 days after the last dose of study drug and have negative results on a serum pregnancy test at the Screening visit and a urine pregnancy test on Day 1.
  6. For male subjects, vasectomized more than 6 months prior to study drug administration, or if non-vasectomized are required to practice reliable birth control methods (condom) or female partner of childbearing potential must use an effective birth control method through 30 days after the last dose of study drug.
  7. Understand the risks and benefits of participation and are able and willing to provide written informed consent
  8. Willing and able to meet all study requirements including collection, handling, storage, and transport of stool samples to clinical site and attending all assessment visits and phone calls

  
  

You may not be eligible for this study if the following are true:

• 1. Body mass index greater than or equal to 40.0 kg/m2
  2. Life expectancy of less than or equal to 12 months
  3. Inpatient (in hospital or skilled nursing facility) at the time of randomization
  4. Current (i.e., qualifying) CDI episode required admission to an Intensive Care Unit
  5. Pregnant, breastfeeding, or seeking pregnancy while on study
  6. Have, as determined by the Investigator, a history or clinical/laboratory manifestations of significant neurological, renal, hepatic, hematologic, cardiac, pulmonary, metabolic, endocrine, psychiatric, gastrointestinal disorders other than CDI, HIV, HBV, and/or HCV infection, or other condition that could interfere with the evaluation of safety or efficacy, or put the subject at risk of harm from study participation
  7. Have an active malignancy of any type or history of a malignancy within past 5 years
  8. Have an acute febrile illness
  9. Drug, alcohol, or substance dependence
  10. Anticipated hospital admission for any reason while on study
  11. Use of systemic antibiotic therapy for conditions other than CDI
  12. Have a known immunodeficiency disorder
  13. Previous fecal transplant or live biotherapeutic product
  14. Treatment with bezlotoxumab (Zinplava™) for the qualifying CDI episode
  15. Diagnosis of inflammatory bowel disease
  16. Active irritable bowel syndrome
  17. Celiac disease not well controlled on gluten-free diet
  18. Active gastroparesis, toxic megacolon, pseudomembranous colitis, colostomy, intestinal resection (except appendectomy), ileus or short gut syndrome
  19. History of chronic diarrhea apart from prior CDI
  20. Intra-abdominal surgery
  21. History of difficulty swallowing food or liquids
  22. Taking antidiarrheal agents (e.g., loperamide) or laxatives (e.g., senna) on a regular basis
  23. Use of non-dietary probiotic supplements