Probiotics at the Treatment of Antibiotic Associated Diarrhea

Antibiotic-Associated Diarrhea Clinical Trial

Official title:

Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700557
• Other study ID #: changeme-12332111
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2008
• Last updated: August 24, 2009
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antibiotic-Associated Diarrhea
• Diarrhea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlândia	Uberlândia	MG

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.		After 24 hours of the intervention started	No