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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
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antibiotic-Associated Diarrhea focused on measuring Antibiotic Associated Diarrhea, probiotics, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 15, 2008
Last Updated
August 24, 2009
Sponsor
Federal University of Uberlandia
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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

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Probiotics at the Treatment of Antibiotic Associated Diarrhea

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