Safety and Feasibility of Kefir Administration in Critically Ill Adults

Early Phase 1

Completed

• Conditions: Critically Ill
• Interventions: Dietary Supplement: Kefir

• Registration Number: NCT05416814
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-13
• Study Start: 2022-07-12
• Primary Completion: 2023-02-04
• Status Verified: 2023-12
• Study Completion: 2023-12-03
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Critically ill adult patients receiving antibiotics.
• Functional GI tract (able to tolerate oral diet or tube feeding).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kefir administration in critically ill adults	Kefir	Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States