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Probiotic
Safety and Feasibility of Kefir Administration in Critically Ill Adults
Phase < 1
Waitlist Available
Led By Lioudmila Karnatovskaia, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if giving kefir, a drink with good bacteria, is safe and helpful for very sick adults. Kefir is a fermented milk drink with probiotic properties, historically used for its health benefits in various conditions.
Eligible Conditions
- Critically Ill Patients
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Feasibility of Kefir administration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Kefir administration in critically ill adultsExperimental Treatment1 Intervention
Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Kefir
2020
Completed Early Phase 1
~380
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,969 Total Patients Enrolled
Lioudmila Karnatovskaia, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
340 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an artificial heart valve.You have a very serious illness and are not expected to survive the treatment period.You are currently taking probiotic supplements.You are an adult who is very sick and currently taking antibiotics.You have had surgery on your intestines, have a history of cancer or bleeding in your digestive system, or have a condition called inflammatory bowel disease.You are unable to tolerate dairy products or have an allergy to milk.You can eat food normally or receive nutrients through a feeding tube without any problems.
Research Study Groups:
This trial has the following groups:- Group 1: Kefir administration in critically ill adults
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.