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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT00364650
Eligibility Criteria:
Inclusion Criteria:
* all subjects aged \>/= 18 years who qualify to receive a living (related or unrelated) or cadaveric kidney allograft using steroid free induction immunosuppression.
* single organ recipient (kidney only)
* subjects receiving first or second renal transplant
* women of child-bearing potential should have a negative serum pregnancy test within 1 week prior to beginning study medications
* subjects with no known contraindications to treatment with any of the study drugs
* subjects providing written consent
* subjects who are compliant and able to complete all the necessary assessment procedures
Exclusion Criteria:
* Subjects \< 18 years of age
* Subjects who do not meet criteria for steroid free protocol
* subjects with known intolerance to lactobacillus
* subjects with history of chronic diarrhea
* subjects with history of gastrointestinal disorder that may interfere with their ability to absorb oral medication: inflammatory bowel disease, irritable bowel syndrome, short gut syndrome, or ileo jejunal surgery
* subjects with known laxative abuse
* subjects with pancreatic insufficiency
* subjects who are pregnant, lactating or nursing
* subjects with active peptic ulcer disease
* child bearing women not willing to use a reliable form of contraception
* subjects with prior history of C. difficile
* subjects receiving other medications considered to be experimental for control of diarrhea
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00364650
Study Brief:
Protocol Section:
NCT00364650