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Antibiotic-associated Diarrhea | Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile

Antibiotic-associated Diarrhea research study

What is the primary objective of this study?

The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.

Who is eligible to participate?

Inclusion Criteria: - Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea - able to understand and sign informed consent and HIPPA - available throughout the study period - subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol Exclusion Criteria: - three or more soft and unformed or watery stools per day at admission - receiving chemotherapy or radiation therapy - diagnosis of inflammatory bowel disease - NPO without PO meds - neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL) - HIV positive with a CD4+ T-lymphocyte count <400 per mcL blood - requiring care in an intensive care unit - status-post bowel resection during hospitalization - patient's receiving antibiotics four weeks prior to hospitalization - patient with severe life threatening illness or immunocompromised - pregnancy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Antibiotic-associated Diarrhea

Clostridium Difficile

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Lactobacillus reuteriOne chewable tablet of 1E8 CFU L. reuteri, once per day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

L. reuteri

Identical Placebo

Study Status

Unknown status

Start Date: May 2010

Completed Date: December 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: diarrhea

Secondary Outcome: Severity of diarrhea

Study sponsors, principal investigator, and references

Principal Investigator: Alison L Steiber, PhD, RD, LD

Lead Sponsor: Case Western Reserve University

Collaborator: BioGaia AB

More information:https://clinicaltrials.gov/show/NCT02127814

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