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

NCT ID: NCT02127814

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2017-12-31

Brief 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.

Detailed 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.

Conditions

Antibiotic-associated Diarrhea; Clostridium Difficile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

L. reuteri

Group Type: EXPERIMENTAL

Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

One chewable tablet of 1E8 CFU L. reuteri, once per day

Identical Placebo

Group Type: PLACEBO_COMPARATOR

Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

One chewable tablet of 1E8 CFU L. reuteri, once per day

Interventions

Lactobacillus reuteri

One chewable tablet of 1E8 CFU L. reuteri, once per day

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BioGaia, Probiotic Chewable Tablets

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioGaia AB

INDUSTRY

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Alison Steiber

Adjunct profession

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison L Steiber, PhD, RD, LD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

RES504803

Identifier Type: -

Identifier Source: org_study_id