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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT03388268
Eligibility Criteria:
Inclusion Criteria:
* Stool submitted to the BJH microbiology laboratory for C. difficile testing that tests negative for C. difficile toxins (C. difficile Tox A/B II, Alere, Waltham, MA) as part of routine clinical care and positive by NAAT (Xpert C. difficile, Cepheid, Sunnyvale, CA)
* Clinically significant diarrhea (≥3 diarrheal bowel movements per day or ≥1 diarrheal bowel movement plus abdominal pain)
* ≥18 years of age.
Exclusion Criteria:
* The presence of a condition associated with persistent / prolonged / recurrent diarrhea, including, but not limited to:
* Upcoming chemotherapy
* Previous or upcoming bone marrow/hematopoietic stem cell transplant,
* Leukemia: new, not in remission, or receiving chemotherapy
* Inflammatory bowel disease
* Crohn's disease
* Ulcerative colitis
* Microscopic colitis
* Previous total colectomy
* Previous partial colectomy without return to formed bowel movement or previous resection of colon
* Colostomy or ileostomy
* Unable to follow study procedures
* Not expected to survive until study follow-up is complete
* Allergy or intolerance to oral vancomycin
* A history of CDI in the past 3 months
* Alternate infectious etiology for diarrhea
* Receipt of CDI antibiotic treatment (excluding empiric treatment given while pending EIA results)
* Does not provide consent will exclude a patient from participating in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03388268
Study Brief:
Protocol Section:
NCT03388268