Trial Outcomes & Findings for Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir (NCT NCT02707198)
NCT ID: NCT02707198
Last Updated: 2022-05-19
Results Overview
The overall incidence of diarrhea, represented as a percentage of patients, that develop diarrhea during the course of their enrollment in the study (an average of 35 days).
TERMINATED
PHASE2
2 participants
Assessed daily during hospitalization and daily for up to 30 days post-discharge; data will be represented as an overall incidence of diarrhea for all compliant patients upon study completion (average tracking time per patient is 35 days).
2022-05-19
Participant Flow
The objective is to identify a population of at-risk patients that are undergoing treatment at St. Luke's Hospital (Duluth, MN) and CHI Creighton University Medical Center (Omaha, NE). The study will include patients who have been prescribed a systemic antibiotic of any kind (administered by oral or parenteral route), but have not yet begun the treatment regimen.
None, participants are randomized prior to any study activities
Participant milestones
| Measure |
Group A
Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
|
Group B
Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
kefir: 4 ounces of kefir 3 times a day, with or without food.
|
Group C
Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
kefir: 4 ounces of kefir 3 times a day, with or without food.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There was not a sufficient patient population that qualified to participate in the study at our site.
Baseline characteristics by cohort
| Measure |
Group A
n=2 Participants
Will receive prescribed antibiotics and will not receive kefir. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
|
Group B
Will receive prescribed antibiotics and will receive kefir only during hospital stay. Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
kefir: 4 ounces of kefir 3 times a day, with or without food.
|
Group C
Will receive prescribed antibiotics and will receive kefir during hospital stay and for the duration of the prescribed antibiotic regimen for up to a total of 30 days . Patients in this arm will be asked to record daily symptoms of diarrhea for up to 30 days post-discharge.
kefir: 4 ounces of kefir 3 times a day, with or without food.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
—
|
—
|
0 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
—
|
—
|
2 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
—
|
—
|
0 Participants
n=2 Participants • There was not a sufficient patient population that qualified to participate in the study at our site.
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Assessed daily during hospitalization and daily for up to 30 days post-discharge; data will be represented as an overall incidence of diarrhea for all compliant patients upon study completion (average tracking time per patient is 35 days).Population: Insufficient number of eligible participants enrolled and data were not collected
The overall incidence of diarrhea, represented as a percentage of patients, that develop diarrhea during the course of their enrollment in the study (an average of 35 days).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at any point during a patient's enrollment in the study (average of 35 days) when clinical symptoms require a C. difficile test per standard of care. Individual patients are tracked for an average of 35 days; data reported at study completionPopulation: Insufficient number of eligible participants enrolled and data were not collected
The overall incidence of C. difficile infections, represented as a percentage of patients, that develop diarrhea during the course of their enrollment in the study (an average of 35 days).
Outcome measures
Outcome data not reported
Adverse Events
Group A
Group B
Group C
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lynsie Radovich, PhD
Whiteside Institute for Clinical Research/St. Luke's Hospital Duluth
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place