Probiotics at the Treatment of Antibiotic Associated Diarrhea

Federal University of Uberlandia

Status and phase: Completed; Phase 4

Conditions: Antibiotic-Associated Diarrhea

Treatments: Dietary Supplement: Maize starch; Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve

Study type: Interventional

Funder types: Other

Identifiers

NCT00700557

changeme-12332111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Probiotics - Lactobacillus casei and Bifidobacterium breve

Active Comparator group

Description:

Yakult LB® 1 sachet (1g) of Lactobacillus casei and Bifidobacterium breve - 6 x 108 UFC/g on a juice three times a day

Treatment:

Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve

maize starch

Placebo Comparator group

Description:

725mg on juice three times a day

Treatment:

Dietary Supplement: Maize starch