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NCT05416814 Clinical Trial

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
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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