Safety and Feasibility of Kefir Administration in Critically Ill Adults
NCT ID: NCT05416814
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
54 participants
INTERVENTIONAL
2022-07-12
2023-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Kefir administration in critically ill adults
Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen
Kefir
Oral route (via feeding tube in intubated patients). Serving size 240mL to be given in an ascending dosing regimen if tolerated starting at 60 mL/day, 120 mL/day until single 240 mL/day; if evidence of intolerance, dose will be reduced to previously tolerated dose.
Interventions
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Kefir
Oral route (via feeding tube in intubated patients). Serving size 240mL to be given in an ascending dosing regimen if tolerated starting at 60 mL/day, 120 mL/day until single 240 mL/day; if evidence of intolerance, dose will be reduced to previously tolerated dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Functional GI tract (able to tolerate oral diet or tube feeding).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Lioudmila Karnatovskaia
Principal Investigator
Principal Investigators
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Lioudmila Karnatovskaia, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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References
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Gupta VK, Rajendraprasad S, Ozkan M, Ramachandran D, Ahmad S, Bakken JS, Laudanski K, Gajic O, Bauer B, Zec S, Freeman DW, Khanna S, Shah A, Skalski JH, Sung J, Karnatovskaia LV. Safety, feasibility, and impact on the gut microbiome of kefir administration in critically ill adults. BMC Med. 2024 Feb 20;22(1):80. doi: 10.1186/s12916-024-03299-x.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-005687
Identifier Type: -
Identifier Source: org_study_id