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Probiotics at the Treatment of Antibiotic Associated Diarrhea

This study has been completed.
Information provided by:
Federal University of Uberlandia Identifier:
First received: May 15, 2008
Last updated: August 24, 2009
Last verified: August 2009
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: Maize starch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study

Resource links provided by NLM:

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 ]

Enrollment: 70
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics - Lactobacillus casei and Bifidobacterium breve

Yakult LB®

1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day

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.
Placebo Comparator: maize starch
725mg on juice 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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,
  • Crohn´s disease,
  • Hydroelectrolytic disturbance,
  • Small intestine syndrome,
  • Colostomized, jejunostomized
  • Lactose intolerance,
  • Rapid enteral diet infusion (>120mh/h),
  • Hyperosmolar enteral diet.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00700557

Federal University of Uberlândia
Uberlândia, MG, Brazil, 38400-902
Sponsors and Collaborators
Federal University of Uberlandia
Principal Investigator: Miguel T Jorge, Medicine Federal University of Uberlandia
  More Information

Responsible Party: Faculdade de Medicina (FAMED), Agnaldo Coelho da Silva Identifier: NCT00700557     History of Changes
Other Study ID Numbers: changeme-12332111
Study First Received: May 15, 2008
Last Updated: August 24, 2009

Keywords provided by Federal University of Uberlandia:
Antibiotic Associated Diarrhea

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 25, 2017