Probiotics in the Reduction of Antibiotic Associated Diarrhea

Clostridium Difficile Clinical Trial

— Probiotics  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589964
• Other study ID #: 13085
• Status: Terminated
• Phase: Phase 1
• First received: April 13, 2015
• Last updated: October 27, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	TriHealth	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Length of stay		during hospitalization up to 4 weeks	No
Secondary	Mortality		During hospitalization up to 4 weeks	No
Secondary	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	No
Secondary	Clostridium difficile	Data is obtained though a follow-up call to the patient.	21 days after initiating study treatment	No