Back to resultsSafety and Feasibility of Kefir Administration in Critically Ill Adults
Primary Purpose
Critically Ill
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Kefir
Sponsored by
About this trial
This is an interventional other trial for Critically Ill
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kefir administration in critically ill adults
Arm Description
Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416814
Brief Title
Safety and Feasibility of Kefir Administration in Critically Ill Adults
Official Title
Safety and Feasibility of Kefir Administration in Critically Ill Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
February 4, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kefir administration in critically ill adults
Arm Type
Experimental
Arm Description
Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen
Intervention Type
Dietary Supplement
Intervention Name(s)
Kefir
Other Intervention Name(s)
Lifeway Foods® Original Kefir Unsweetened Whole Milk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
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
Time Frame
30 days
Title
Feasibility of Kefir administration
Description
Number of subjects to have more than 75% of doses given when subject is allowed to have PO/feeding tube administration and are tolerated
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lioudmila Karnatovskaia, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Safety and Feasibility of Kefir Administration in Critically Ill Adults
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