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The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kefir administration in critically ill adults | Experimental | Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kefir | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse effects related to kefir administration including vomiting, aspiration, diarrhea, interactions with medications or tube feeds, bacteremia secondary to a bacterium in kefir | 30 days |
| Feasibility of Kefir administration | Number of subjects to have more than 75% of doses given when subject is allowed to have PO/feeding tube administration and are tolerated | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lioudmila Karnatovskaia, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38378568 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000070716 | Kefir |
| ID | Term |
|---|---|
| D000088082 | Fermented Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| D043302 |
| Cultured Milk Products |
| D008892 | Milk |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |