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

NCT02127814 | Completed

• 1 other identifier: RES504803
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic-associated Diarrhea; Clostridium Difficile

Keywords

induced diarrhea; Clostridium difficile toxicity

Outcome Measures

Primary Outcomes (1)

• diarrhea

  Instances of diarrhea

  28+ days

Secondary Outcomes (3)

• Severity of diarrhea

  28+ days

• Frequency of stool samples positive for C. difficile toxin A and B

  baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days

• Frequencies of other gastrointestinal symptoms

  1, 2 and 4 weeks

Study Arms (2)

L. reuteri

EXPERIMENTAL

Dietary Supplement: Lactobacillus reuteri

Identical Placebo

PLACEBO COMPARATOR

Dietary Supplement: Lactobacillus reuteri

Interventions

Lactobacillus reuteri DIETARY_SUPPLEMENT

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

Also known as: BioGaia, Probiotic Chewable Tablets

Identical Placebo; L. reuteri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• BioGaia AB: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Alison L Steiber, PhD, RD, LD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct profession

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: May 1, 2014
• Study Start: May 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: December 31, 2017
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)