Safety and Feasibility of Kefir Administration in Critically Ill Adults

Critically Ill Clinical Trial

Official title:

Safety and Feasibility of Kefir Administration in Critically Ill Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416814
• Other study ID #: 20-005687
• Status: Completed
• Phase: Early Phase 1
• Start date: July 12, 2022
• Est. completion date: December 3, 2023

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 3, 2023
• Est. primary completion date: February 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials