Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
Time Frame: After 24 hours of the intervention started
Secondary Outcomes
No secondary outcomes reported