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Sponsored by: |
Federal University of Uberlandia |
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Information provided by: | Federal University of Uberlandia |
ClinicalTrials.gov Identifier: | NCT00700557 |
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.
Condition | Intervention | Phase |
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Antibiotic-Associated Diarrhea |
Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve Dietary Supplement: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study |
Estimated Enrollment: | 80 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
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 - 2x 107 UFC/g and Bifidobacterium breve - 5x 107 UFC/g) three times a day.
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2: Placebo Comparator |
Dietary Supplement: Placebo
Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Miguel T Jorge, Medicine | (34) 3218- 2224 | miglind@ufu.br |
Contact: Daniela N Souza, Nutrition | (34) 3224-4788 | danielanps@yahoo.com.br |
Brazil, mg | |
Federal University of Uberlândia | Recruiting |
Uberlândia, mg, Brazil, 38400-902 | |
Contact: Miguel T Jorge, Medicine (34) 3218-2224 miglind@ufu.br | |
Contact: Daniela N Souza, Nutrition (34) 3224-4788 danielanps@yahoo.com.br | |
Principal Investigator: Miguel T Jorge, Medicine | |
Sub-Investigator: Daniela N Souza, Nutrition |
Principal Investigator: | Miguel T Jorge, Medicine | Federal University of Uberlândia |
Responsible Party: | Agnaldo Coelho da Silva ( Faculdade de Medicina (FAMED) ) |
Study ID Numbers: | changeme-12332111 |
Study First Received: | May 15, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00700557 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Antibiotic Associated Diarrhea, probiotics, treatment. |
Signs and Symptoms Diarrhea Signs and Symptoms, Digestive |