Safety and Feasibility of Kefir Administration in Critically Ill Adults

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Critically Ill

Treatments: Dietary Supplement: Kefir

Study type: Interventional

Funder types: Other

Identifiers

NCT05416814

20-005687

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Kefir administration in critically ill adults

Experimental group

Description:

Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen

Treatment:

Dietary Supplement: Kefir