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Probiotics in the Reduction of Antibiotic Associated Diarrhea (Probiotics)

Primary Purpose

Clostridium Difficile

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Florajen-3

Placebo

About this trial

This is an interventional prevention trial for Clostridium Difficile focused on measuring probiotics, antibiotic associated diarrhea, clostridium difficile

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

TriHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay

Mortality

Healthcare costs

Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department.

Clostridium difficile

Data is obtained though a follow-up call to the patient.

Full Information

NCT ID

NCT02589964

First Posted

April 13, 2015

Last Updated

October 27, 2016

Sponsor

TriHealth Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02589964

Brief Title

Probiotics in the Reduction of Antibiotic Associated Diarrhea

Acronym

Probiotics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

Low Recruitment

Study Start Date

March 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TriHealth Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile

Keywords

probiotics, antibiotic associated diarrhea, clostridium difficile

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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

Intervention Type

Dietary Supplement

Intervention Name(s)

Florajen-3

Other Intervention Name(s)

probiotic

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Antibiotic Associated Diarrhea

Description

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

Time Frame

21 days after starting study treatment

Secondary Outcome Measure Information:

Title

Length of stay

Time Frame

during hospitalization up to 4 weeks

Title

Mortality

Time Frame

During hospitalization up to 4 weeks

Title

Healthcare costs

Description

Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department.

Time Frame

During hospitalization up to 4 weeks

Title

Clostridium difficile

Description

Data is obtained though a follow-up call to the patient.

Time Frame

21 days after initiating study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amita Buddhdev, MD

Organizational Affiliation

TriHealth Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

TriHealth

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45244

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The study was closed due to poor recruitment, so there is no data to share.

Learn more about this trial

Probiotics in the Reduction of Antibiotic Associated Diarrhea

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