Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Probiotics at the Treatment of Antibiotic Associated Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT00700557
First received: May 15, 2008
Last updated: August 24, 2009
Last verified: August 2009

May 15, 2008
August 24, 2009
October 2006
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00700557 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Antibiotic-Associated Diarrhea
  • 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.
  • 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

    Intervention: Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve
  • Placebo Comparator: maize starch
    725mg on juice three times a day
    Intervention: Dietary Supplement: Maize starch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00700557
changeme-12332111
Yes
Faculdade de Medicina (FAMED), Agnaldo Coelho da Silva
Federal University of Uberlandia
Not Provided
Principal Investigator: Miguel T Jorge, Medicine Federal University of Uberlandia
Federal University of Uberlandia
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP