Probiotics in the Reduction of Antibiotic Associated Diarrhea

Phase 1

Terminated

• Conditions: Clostridium Difficile
• Interventions: Dietary Supplement: Florajen-3; Other: Placebo

• Registration Number: NCT02589964
• Lead Sponsor: TriHealth Inc.

Brief Summary

The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.

Detailed Description

The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-13
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Admitted to Good Samaritan Hospital
• Placed on pneumonia order set
• Age 18+

Exclusion Criteria

• Patient with inadequate coherency to understand consent
• Active Diarrhea at admission
• Non-controlled intestinal disease
• Documented positive C. difficile infection within the 3 months before enrollment
• Antibiotic use at hospital admission
• Immunosuppressive therapy
• Pregnancy
• Allergic to ingredients in Florajen-3
• Allergic to ingredients in placebo
• Immunocompromised state including:
• HIV with a low CD4 count
• Active malignancy receiving chemotherapy
• Medications including long-term steroids (>2 weeks), and disease modifying biologic agents
• Acquired immune deficiency
• Unable to take oral medication
• Less than 4 doses of probiotic or placebo
• Taking probiotic in the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Florajen-3	Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are: Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion
Placebo	Placebo	Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are: Rice maltodextrin

Primary Outcome Measures

Name	Time	Method
Antibiotic Associated Diarrhea	21 days after starting study treatment	Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment

Secondary Outcome Measures

Name	Time	Method
Length of stay	during hospitalization up to 4 weeks
Mortality	During hospitalization up to 4 weeks
Healthcare costs	During hospitalization up to 4 weeks	Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department.
Clostridium difficile	21 days after initiating study treatment	Data is obtained though a follow-up call to the patient.

Trial Locations

Locations (1)

TriHealth; 🇺🇸 Cincinnati, Ohio, United States