Safety and Feasibility of Kefir Administration in Critically Ill Adults

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

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Dietary supplement: Kefir

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kefir administration in critically ill adults; Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen	Dietary supplement: 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 Names: Lifeway Foods® Original Kefir Unsweetened Whole Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Lioudmila Karnatovskaia, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): February 4, 2023
• Study Completion (Actual): December 3, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 20-005687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No