drugset / Trial / NCT02707198
Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir
RandomizedFactorialOpen-labelPrevention
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?
Timeline
- Start
- 2015-11
- Primary completion
- 2019-05-10
- Completion
- 2019-05-10
Outcome
Outcome not reported
Stopped: “Study was not feasible to complete at study site”
Publications
- Background 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.
- 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.
- 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.
- 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.
- Background Bakken JS. Resolution of recurrent Clostridium difficile-associated diarrhea using staggered antibiotic withdrawal and kefir. Minn Med. 2009 Jul;92(7):38-40.
- 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.
- 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.
- 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.
- Background Su, Yu-Sung, et al.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | kefir | Unknown | 4 unknown | Oral |