Trial | NCT00700557  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    70
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.
Study Started
Oct 31
2006
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Aug 25
2009
Estimate

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.

Probiotics - Lactobacillus casei and Bifidobacterium breve Active Comparator

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

maize starch Placebo Comparator

725mg on juice three times a day

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,
Crohn´s disease,
Hydroelectrolytic disturbance,
Small intestine syndrome,
Colostomized, jejunostomized
Lactose intolerance,
Rapid enteral diet infusion (>120mh/h),
Hyperosmolar enteral diet.
No Results Posted