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Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707198
Recruitment Status : Terminated (Study was not feasible to complete at study site)
First Posted : March 14, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
St. Luke's Hospital of Duluth

Brief Summary:
This study is being conducted to investigate the potential benefits of probiotic intake for preventing antibiotic associated diarrhea and Clostridium difficile infection in patients undergoing a systemic antibiotic treatment. The primary research question is: can daily intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea and Clostridium difficile infection in patients during antibiotic treatment?

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Diarrhea Drug: kefir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir
Study Start Date : November 2015
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
Drug: kefir
4 ounces of kefir 3 times a day, with or without food.

Active Comparator: 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.
Drug: kefir
4 ounces of kefir 3 times a day, with or without food.




Primary Outcome Measures :
  1. Incidence of diarrhea among the three randomized study groups over time [ Time Frame: 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). ]
    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).


Secondary Outcome Measures :
  1. Incidence of Clostridium difficile infection among the three randomized study groups over time [ Time Frame: 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 completion ]
    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).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who have:

  • Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN)
  • Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral route), but have not yet started the regimen
  • Consented to be randomized and take part in the study and are adults greater than 19 years of age

Exclusion Criteria:

Patients who are/have:

  • Tube feeding
  • Undergoing dialysis and other renal treatment
  • An existing C. difficile infection
  • A recent history of C. difficile infection (within the last 3 months)
  • A recent history of antibiotic use (within the last 3 months)
  • Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal syndrome
  • A history of acquired of genetic immunodeficiencies; active, acute or chronic serious infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders
  • Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy
  • Allergy to milk protein

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707198


Sponsors and Collaborators
St. Luke's Hospital of Duluth
Investigators
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Principal Investigator: Johan S Bakken, M.D., Ph.D. St. Luke's Hospital of Duluth

Publications:
Su, Yu-Sung, et al.

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Responsible Party: St. Luke's Hospital of Duluth
ClinicalTrials.gov Identifier: NCT02707198    
Other Study ID Numbers: C. diff
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections