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OpenTrials
Completed

NCT Number: NCT05416814

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kefir

Dietary Supplement

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

Primary outcomes

  1. Adverse Events

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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