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

NCT02707198 | Terminated Phase 2 Results

• 1 other identifier: C. diff
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Clostridium Difficile Infection; Diarrhea

Outcome Measures

Primary Outcomes (1)

• Incidence of Diarrhea Among the Three Randomized Study Groups Over Time

  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).

  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).

Secondary Outcomes (1)

• Incidence of Clostridium Difficile Infection Among the Three Randomized Study Groups Over Time

  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

Study Arms (3)

Group A

NO INTERVENTION

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

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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

Interventions

kefir DRUG

4 ounces of kefir 3 times a day, with or without food.

Group B; Group C

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital of Duluth: lead

Related Publications (9)

• Zilberberg MD, Shorr AF, Kollef MH. Increase in adult Clostridium difficile-related hospitalizations and case-fatality rate, United States, 2000-2005. Emerg Infect Dis. 2008 Jun;14(6):929-31. doi: 10.3201/eid1406.071447.

  PMID: 18507904 BACKGROUND

• Gerding DN, Muto CA, Owens RC Jr. Treatment of Clostridium difficile infection. Clin Infect Dis. 2008 Jan 15;46 Suppl 1:S32-42. doi: 10.1086/521860.

  PMID: 18177219 BACKGROUND

• Lo Vecchio A, Cohen MB. Fecal microbiota transplantation for Clostridium difficile infection: benefits and barriers. Curr Opin Gastroenterol. 2014 Jan;30(1):47-53. doi: 10.1097/MOG.0000000000000023.

  PMID: 24275671 BACKGROUND

• Bakken JS. Staggered and tapered antibiotic withdrawal with administration of kefir for recurrent Clostridium difficile infection. Clin Infect Dis. 2014 Sep 15;59(6):858-61. doi: 10.1093/cid/ciu429. Epub 2014 Jun 9.

  PMID: 24917658 BACKGROUND

• Bakken JS. Resolution of recurrent Clostridium difficile-associated diarrhea using staggered antibiotic withdrawal and kefir. Minn Med. 2009 Jul;92(7):38-40.

  PMID: 19708314 BACKGROUND

• Goldenberg JZ, Ma SS, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC. Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children. Cochrane Database Syst Rev. 2013 May 31;(5):CD006095. doi: 10.1002/14651858.CD006095.pub3.

  PMID: 23728658 BACKGROUND

• Bolla PA, Carasi P, Bolla Mde L, De Antoni GL, Serradell Mde L. Protective effect of a mixture of kefir-isolated lactic acid bacteria and yeasts in a hamster model of Clostridium difficile infection. Anaerobe. 2013 Jun;21:28-33. doi: 10.1016/j.anaerobe.2013.03.010. Epub 2013 Mar 29.

  PMID: 23542116 BACKGROUND

• Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.

  PMID: 20307191 BACKGROUND

• Su, Yu-Sung, et al.

  BACKGROUND

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Interventions

Kefir

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Results Point of Contact

• Title: Lynsie Radovich, PhD
• Organization: Whiteside Institute for Clinical Research/St. Luke's Hospital Duluth

lradovic@d.umn.edu

216-726-7940

Study Officials

• Johan S Bakken, M.D., Ph.D.

  St. Luke's Hospital of Duluth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: March 14, 2016
• Study Start: November 1, 2015
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: May 19, 2022
• Results First Posted: May 19, 2022

Record last verified: 2022-05