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

Not Applicable

Terminated

• Conditions: Diarrhea
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT02076438
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	Lactobacillus Rhamnosus GG 10 billion cfu BID
Placebo	Probiotics	Placebo capsules

Primary Outcome Measures

Name	Time	Method
Diarrhea	4 weeks	Diarrhea associated with antibiotics

Secondary Outcome Measures

Name	Time	Method
Tolerability of probiotics	4 weeks	Patient experience with use of probiotics

Trial Locations

Locations (1)

Saint Peters University Hospital; 🇺🇸 New Brunswick, New Jersey, United States