Critically Ill
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.
Interventions
DIETARY_SUPPLEMENTKefir
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critically ill adult patients receiving antibiotics. * Functional GI tract (able to tolerate oral diet or tube feeding).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 days | 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 |
| Feasibility of Kefir administration | 30 days | Number of subjects to have more than 75% of doses given when subject is allowed to have PO/feeding tube administration and are tolerated |
Countries
United States
Outcome results
None listed