Probiotics at the Treatment of Antibiotic Associated Diarrhea
Primary Purpose
Antibiotic-Associated Diarrhea
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Probiotics - Lactobacillus casei and Bifidobacterium breve
Maize starch
Sponsored by
About this trial
This is an interventional treatment trial for Antibiotic-Associated Diarrhea focused on measuring Antibiotic Associated Diarrhea, probiotics, treatment
Eligibility 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.
Sites / Locations
- Federal University of Uberlândia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotics - Lactobacillus casei and Bifidobacterium breve
maize starch
Arm Description
Yakult LB® 1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day
725mg on juice three times a day
Outcomes
Primary Outcome Measures
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Secondary Outcome Measures
Full Information
NCT ID
NCT00700557
First Posted
May 15, 2008
Last Updated
August 24, 2009
Sponsor
Federal University of Uberlandia
1. Study Identification
Unique Protocol Identification Number
NCT00700557
Brief Title
Probiotics at the Treatment of Antibiotic Associated Diarrhea
Official Title
Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Uberlandia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea
Keywords
Antibiotic Associated Diarrhea, probiotics, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics - Lactobacillus casei and Bifidobacterium breve
Arm Type
Active Comparator
Arm Description
Yakult LB®
1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day
Arm Title
maize starch
Arm Type
Placebo Comparator
Arm Description
725mg on juice three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics - Lactobacillus casei and Bifidobacterium breve
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maize starch
Intervention Description
Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.
Primary Outcome Measure Information:
Title
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Time Frame
After 24 hours of the intervention started
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel T Jorge, Medicine
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Uberlândia
City
Uberlândia
State/Province
MG
ZIP/Postal Code
38400-902
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Probiotics at the Treatment of Antibiotic Associated Diarrhea
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