NCT00700557

Probiotics at the Treatment of Antibiotic Associated Diarrhea

Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Federal University of Uberlandia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.

Detailed description

The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.

Conditions

• Antibiotic-Associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics - Lactobacillus casei and Bifidobacterium breve	Experimental group:This group received enteral tube feeding or oral diet plus a juice containing 1 sachet (1g) of probiotics (Lactobacillus casei and Bifidobacterium breve - 6x 108 UFC/g) three times a day.
DIETARY_SUPPLEMENT	Maize starch	Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-06-18
• Last updated: 2009-08-25

Locations

1 site across 1 country: Brazil