Status:
COMPLETED
Safety and Feasibility of Kefir Administration in Critically Ill Adults
Lead Sponsor:
Mayo Clinic
Conditions:
Critically Ill
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.
Eligibility Criteria
Inclusion
- Critically ill adult patients receiving antibiotics.
- Functional GI tract (able to tolerate oral diet or tube feeding).
Exclusion
- Received antibiotics for \>72 hours prior to enrollment.
- Known immunosuppression (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.).
- Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease).
- History of CDI within 60 days.
- Liver failure or pancreatitis.
- Dairy intolerance or milk allergy.
- Patients consuming probiotics at baseline.
- Artificial heart valve.
- Extremely poor prognosis and not expected to survive the treatment period.
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05416814
Start Date
July 12 2022
End Date
December 3 2023
Last Update
December 18 2023
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905