Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial

The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.

Study Overview

• Status: Terminated
• Conditions: Diarrhea
• Intervention / Treatment: Dietary supplement: Probiotics

Detailed Description

Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:

• Diarrhea on admission or within the preceding week
• Reported recurrent diarrhea
• Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
• Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
• Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
• Bowel surgery causing liquid stools
• Regular probiotic intake before admission
• Lactose intolerance or intolerance to dairy products.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08824
      • Saint Peters University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.

Exclusion Criteria:

• Diarrhea on admission or within the preceding week
• Reported recurrent diarrhea
• Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
• Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
• Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
• Bowel surgery causing liquid stools
• Regular probiotic intake before admission
• Lactose intolerance or intolerance to dairy products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules	Dietary supplement: Probiotics; Randomized to receive probiotics or placebo; Other Names: Lactobacillus Rhamnosus GG 10 billion cfu bid
Experimental: Probiotics; Lactobacillus Rhamnosus GG 10 billion cfu BID	Dietary supplement: Probiotics; Randomized to receive probiotics or placebo; Other Names: Lactobacillus Rhamnosus GG 10 billion cfu bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea	Diarrhea associated with antibiotics	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of probiotics	Patient experience with use of probiotics	4 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Saint Peters University Hospital
• Investigators: Principal Investigator: Amita Avadhani, DNP, Rutgers University and Saint Peters University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: diarrhea; antibiotics; Hospitalized patients; c diff
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: Pro2012002450; Grant# PC 14-13 (Other Identifier: New Jersey Health Foundation)