Probiotics at the Treatment of Antibiotic Associated Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT00700557
First received: May 15, 2008
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Antibiotic-Associated Diarrhea
Dietary Supplement: Probiotics - Lactobacillus casei and Bifidobacterium breve
Dietary Supplement: Maize starch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study

Resource links provided by NLM:


Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Reduction of discharge numbers, change the consistency of the feces and occurence of relapses. [ Time Frame: After 24 hours of the intervention started ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

Dietary Supplement: 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.
Placebo Comparator: maize starch
725mg on juice three times a day
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700557

Locations
Brazil
Federal University of Uberlândia
Uberlândia, MG, Brazil, 38400-902
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Miguel T Jorge, Medicine Federal University of Uberlandia
  More Information

No publications provided

Responsible Party: Faculdade de Medicina (FAMED), Agnaldo Coelho da Silva
ClinicalTrials.gov Identifier: NCT00700557     History of Changes
Other Study ID Numbers: changeme-12332111
Study First Received: May 15, 2008
Last Updated: August 24, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
Antibiotic Associated Diarrhea
probiotics
treatment

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014