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

Clostridium Difficile Clinical Trial

Official title:

Efficacy and Safety of the Probiotic Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile Related Infections in Hospitalized Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127814
• Other study ID #: RES504803
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2019
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The data being measured for this study include:

Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.

Secondary variables:

1. severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.

2. frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.

3. frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 31, 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Clostridium Difficile
• Diarrhea

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	BioGaia AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diarrhea	Instances of diarrhea	28+ days
Secondary	Severity of diarrhea	measured as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return.	28+ days
Secondary	Frequency of stool samples positive for C. difficile toxin A and B	Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post antibiotic-treatment to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo.	baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days
Secondary	Frequencies of other gastrointestinal symptoms	Frequencies of other gastrointestinal symptoms at 1, 2 and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score).	1, 2 and 4 weeks