Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.
You may not be if
1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
3. GI surgery within 6 weeks before the day of randomization
4. Have known immunodeficiency disorder, such as HIV Infection
5. Pregnant or breast feeding females.
6. Concurrent acute life-threatening diseases.
7. Inability to tolerate oral liquids.
8. Have an absolute neutrophil count \< 1000/mm3 at screening
Clareo Health | Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
