Probiotics at the Treatment of Antibiotic Associated Diarrhea

NCT ID: NCT00700557

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

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.

Conditions

Antibiotic-Associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotics - Lactobacillus casei and Bifidobacterium breve

Yakult LB®

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

Group Type: ACTIVE_COMPARATOR

Probiotics - Lactobacillus casei and Bifidobacterium breve

Intervention Type: DIETARY_SUPPLEMENT

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.

maize starch

725mg on juice three times a day

Group Type: PLACEBO_COMPARATOR

Maize starch

Intervention Type: DIETARY_SUPPLEMENT

Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.

Interventions

Probiotics - Lactobacillus casei and Bifidobacterium breve

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

Maize starch

Placebo group: This groups received enteral tube feeding or oral diet plus a juice containing,approximately, 725mg of placebo three times a day.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Agnaldo Coelho da Silva

Principal Investigators

Miguel T Jorge, Medicine

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Federal University of Uberlândia

Uberlândia, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

changeme-12332111

Identifier Type: -

Identifier Source: org_study_id