Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT03110133
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent
* Men or women 18 years of age or older
* Current diagnosis of a recurrence of non-severe, non-complicated CDI
* Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode
Exclusion Criteria:
* Pregnant, breast-feeding, or considering becoming pregnant during the study
* Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
* Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
* Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
* Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
* Major intra-abdominal surgery within the past 60 days prior to Screening
* History of total colectomy/ileostomy or bariatric surgery
* Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
* Planned hospitalization or invasive surgery during the study
* Severe acute illness unrelated to CDI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03110133
Study Brief:
Protocol Section:
NCT03110133