Probiotics at the Treatment of Antibiotic Associated Diarrhea

August 24, 2009 updated by: Federal University of Uberlandia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Uberlândia, MG, Brazil, 38400-902
        • Federal University of Uberlândia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Time Frame: After 24 hours of the intervention started
After 24 hours of the intervention started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Miguel T Jorge, Medicine, Federal University of Uberlândia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • changeme-12332111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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