Probiotics in the Reduction of Antibiotic Associated Diarrhea (Probiotics)

Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital

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.

Study Overview

• Status: Terminated
• Conditions: Clostridium Difficile
• Intervention / Treatment: Dietary supplement: Florajen-3; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45244
      • TriHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; 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	Dietary supplement: Florajen-3; The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.; Other Names: probiotic
Placebo Comparator: 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	Other: Placebo; The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Associated Diarrhea	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	21 days after starting study treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Amita Buddhdev, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: probiotics; clostridium difficile; antibiotic associated diarrhea
• Additional Relevant MeSH Terms: Infections; Signs and Symptoms, Digestive; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Diarrhea; Clostridium Infections
• Other Study ID Numbers: 13085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study was closed due to poor recruitment, so there is no data to share.