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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700557

Enrollment

Registered

2008-06-18

Start date

2006-10-31

Completion date

2008-12-31

Last updated

2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-Associated Diarrhea

Keywords

Antibiotic Associated Diarrhea, probiotics, treatment

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.

Interventions

DIETARY_SUPPLEMENTProbiotics - 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.

DIETARY_SUPPLEMENTMaize starch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.	After 24 hours of the intervention started

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026