Probiotics at the Treatment of Antibiotic Associated Diarrhea
Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 25, 2009
August 1, 2009
2.2 years
May 15, 2008
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
After 24 hours of the intervention started
Study Arms (2)
Probiotics - Lactobacillus casei and Bifidobacterium breve
ACTIVE COMPARATORYakult LB® 1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day
maize starch
PLACEBO COMPARATOR725mg on juice three times a day
Interventions
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 group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.
Eligibility Criteria
You may qualify if:
- Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Uberlândia
Uberlândia, Minas Gerais, 38400-902, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel T Jorge, Medicine
Federal University of Uberlandia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 15, 2008
First Posted
June 18, 2008
Study Start
October 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 25, 2009
Record last verified: 2009-08