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

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ClinicalTrials.gov Identifier: NCT02076438
Recruitment Status : Terminated (Lack of recruitment)
First Posted : March 3, 2014
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
Saint Peters University Hospital
Information provided by (Responsible Party):
Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN, Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Probiotics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules
Dietary Supplement: Probiotics
Randomized to receive probiotics or placebo
Other Name: 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 Name: Lactobacillus Rhamnosus GG 10 billion cfu bid




Primary Outcome Measures :
  1. Diarrhea [ Time Frame: 4 weeks ]
    Diarrhea associated with antibiotics


Secondary Outcome Measures :
  1. Tolerability of probiotics [ Time Frame: 4 weeks ]
    Patient experience with use of probiotics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076438


Locations
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United States, New Jersey
Saint Peters University Hospital
New Brunswick, New Jersey, United States, 08824
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Saint Peters University Hospital
Investigators
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Principal Investigator: Amita Avadhani, DNP Rutgers University and Saint Peters University Hospital
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Responsible Party: Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN, Assistant Professor/Director Post MSN-DNP program, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02076438    
Other Study ID Numbers: Pro2012002450
Grant# PC 14-13 ( Other Identifier: New Jersey Health Foundation )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Keywords provided by Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN, Rutgers, The State University of New Jersey:
antibiotics
diarrhea
c diff
Hospitalized patients
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive