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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02076438
• Other study ID #: Pro2012002450
• Secondary ID: Grant# PC 14-13
• Status: Terminated
• Phase: N/A
• First received: February 25, 2014
• Last updated: November 22, 2016
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

Intervention

Dietary Supplement:
• Probiotics
Randomized to receive probiotics or placebo

Locations

Country	Name	City	State
United States	Saint Peters University Hospital	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Saint Peters University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea	Diarrhea associated with antibiotics	4 weeks	No
Secondary	Tolerability of probiotics	Patient experience with use of probiotics	4 weeks	No