Probiotics in the Reduction of Antibiotic Associated Diarrhea

TriHealth

Status and phase: Terminated; Phase 1

Conditions: Clostridium Difficile

Treatments: Other: Placebo; Dietary Supplement: Florajen-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02589964

13085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Florajen-3

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo