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

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Amita Avadhani, DNP; Rutgers University and Saint Peters University Hospital

More Information

• 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
• 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:

Diarrhea; Signs and Symptoms, Digestive