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A Study to Evaluate Kefir in Patients Taking Antibiotics

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05416814
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
10.6
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Kefir
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Safety and Feasibility of Kefir Administration in Critically Ill Adults
Actual Study Start Date :
Jul 12, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Lioudmila Karnatovskaia, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Lioudmila Karnatovskaia, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05416814
    Other Study ID Numbers:
    • 20-005687
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Aug 3, 2022