Probiotics at the Treatment of Antibiotic Associated Diarrhea

Phase 4

Completed

• Conditions: Antibiotic-Associated Diarrhea
• Interventions: Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve; Dietary Supplement: Maize starch

• Registration Number: NCT00700557
• Lead Sponsor: Federal University of Uberlandia

Brief 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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics - Lactobacillus casei and Bifidobacterium breve	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
maize starch	Maize starch	725mg on juice three times a day

Primary Outcome Measures

Name	Time	Method
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.	After 24 hours of the intervention started

Trial Locations

Locations (1)

Federal University of Uberlândia; 🇧🇷 Uberlândia, MG, Brazil