Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study - Full Text View

Sponsored by:	Federal University of Uberlandia
Information provided by:	Federal University of Uberlandia
ClinicalTrials.gov Identifier:	NCT00700557

Purpose

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
Antibiotic-Associated Diarrhea	Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve Dietary Supplement: Placebo	Phase IV

MedlinePlus related topics: Antibiotics Diarrhea Dietary Supplements

Drug Information available for: Lactobacillus casei

U.S. FDA Resources

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

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:

Reduction of discharge numbers, change the consistency of the feces and occurence of relapses. [ Time Frame: After 24 hours of the intervention started ] [ Designated as safety issue: No ]

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
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.
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.

Exclusion Criteria:

Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
HIV infections,
Ulcerative colitis,
Crhon´s disease,
Hydroelectrolytic disturbance,
Small intestine syndrome,
Lactose intolerance,
Rapid enteral diet infusion (>120mh/h),
Refrigerator temperature enteral diet or
Hyperosmolar enteral diet.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700557

Contacts

Contact: Miguel T Jorge, Medicine	(34) 3218- 2224	miglind@ufu.br
Contact: Daniela N Souza, Nutrition	(34) 3224-4788	danielanps@yahoo.com.br

Locations

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

Sponsors and Collaborators

Federal University of Uberlandia

Investigators

Principal Investigator:

Miguel T Jorge, Medicine

Federal University of Uberlândia

More Information

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

Keywords provided by Federal University of Uberlandia:

Antibiotic Associated Diarrhea, probiotics, treatment.

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on January 16, 2009