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

Primary Purpose

Diarrhea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotics
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring antibiotics, diarrhea, c diff, Hospitalized patients

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint Peters University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotics

Arm Description

Placebo capsules

Lactobacillus Rhamnosus GG 10 billion cfu BID

Outcomes

Primary Outcome Measures

Diarrhea
Diarrhea associated with antibiotics

Secondary Outcome Measures

Tolerability of probiotics
Patient experience with use of probiotics

Full Information

First Posted
February 25, 2014
Last Updated
November 22, 2016
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Saint Peters University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02076438
Brief Title
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease
Official Title
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Saint Peters University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
antibiotics, diarrhea, c diff, Hospitalized patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Lactobacillus Rhamnosus GG 10 billion cfu BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
Lactobacillus Rhamnosus GG 10 billion cfu bid
Intervention Description
Randomized to receive probiotics or placebo
Primary Outcome Measure Information:
Title
Diarrhea
Description
Diarrhea associated with antibiotics
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tolerability of probiotics
Description
Patient experience with use of probiotics
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amita Avadhani, DNP
Organizational Affiliation
Rutgers University and Saint Peters University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Peters University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08824
Country
United States

12. IPD Sharing Statement

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

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