Safety and Feasibility of Kefir Administration in Critically Ill Adults

NCT05416814 | Completed Early Phase 1

• 1 other identifier: 20-005687
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Kefir administration in critically ill adults

EXPERIMENTAL

Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen

Dietary Supplement: Kefir

Interventions

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.

Also known as: Lifeway Foods® Original Kefir Unsweetened Whole Milk

Kefir administration in critically ill adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Gupta VK, Rajendraprasad S, Ozkan M, Ramachandran D, Ahmad S, Bakken JS, Laudanski K, Gajic O, Bauer B, Zec S, Freeman DW, Khanna S, Shah A, Skalski JH, Sung J, Karnatovskaia LV. Safety, feasibility, and impact on the gut microbiome of kefir administration in critically ill adults. BMC Med. 2024 Feb 20;22(1):80. doi: 10.1186/s12916-024-03299-x.

  PMID: 38378568 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Critical Illness

Interventions

Kefir

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Lioudmila Karnatovskaia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: July 12, 2022
• Primary Completion: February 4, 2023
• Study Completion: December 3, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)