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Completed

NCT Number: NCT00700557

Probiotics at the Treatment of Antibiotic Associated Diarrhea

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.

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Uberlândia

Uberlândia, Minas Gerais, 38400-902, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics - Lactobacillus casei and Bifidobacterium breve

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

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.

Primary outcomes

  1. Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.

    Time frame: After 24 hours of the intervention started

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 18, 2008
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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