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:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT03806803
Eligibility Criteria:
Inclusion Criteria:
* at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
* CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
* Ability to provide informed consent
* Females and males must agree to effective contraception for the duration of the study
Exclusion Criteria:
* Severe or fulminant colitis
* Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
* Those taking or planning to take an investigational drug within 3 months of enrollment
* Chemotherapy or radiation therapy
* Oropharyngeal or significant esophageal dysphagia
* Ileus or small bowel obstruction
* Pregnant or planning to become pregnant within 3 months
* Breastfeeding or planning to breastfeed during the trial
* Active infection requiring antibiotics
* Life expectancy \<6 months Those with history of total colectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03806803
Study Brief:
Protocol Section:
NCT03806803