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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT03353506
Eligibility Criteria:
Inclusion Criteria:
1. 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 toxin, each occurring within 3 months of each other.
2. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
3. Ability to provide informed consent.
4. Females and males must agree to use effective contraception for the duration of the study as applicable
Exclusion Criteria:
1. Complicated CDI defined as WBC \>35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure \<90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
2. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
3. Taking or planning to take an investigational drug within 3 months of enrollment.
4. Immunosuppression
5. Chemotherapy or radiation therapy
6. oropharyngeal or significant esophageal dysphagia
7. Ileus or small bowel obstruction
8. Subtotal colectomy
9. Pregnancy or planning to become pregnant within 3 months of enrollment
10. Breastfeeding or planning to breastfeed during the trial
11. Active infection requiring antibiotic therapy.
12. Life expectancy \<6 months -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03353506
Study Brief:
Protocol Section:
NCT03353506