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Probiotics in the Reduction of Antibiotic Associated Diarrhea (Probiotics)

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ClinicalTrials.gov Identifier: NCT02589964
Recruitment Status : Terminated (Low Recruitment)
First Posted : October 28, 2015
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Jenni Steinbrunner, 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Dietary Supplement: Florajen-3 Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

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 Name: 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.




Primary Outcome Measures :
  1. Antibiotic Associated Diarrhea [ Time Frame: 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 :
  1. Length of stay [ Time Frame: during hospitalization up to 4 weeks ]
  2. Mortality [ Time Frame: During hospitalization up to 4 weeks ]
  3. Healthcare costs [ Time Frame: 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.

  4. Clostridium difficile [ Time Frame: 21 days after initiating study treatment ]
    Data is obtained though a follow-up call to the patient.



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589964


Locations
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United States, Ohio
TriHealth
Cincinnati, Ohio, United States, 45244
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Amita Buddhdev, MD TriHealth Inc.

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Responsible Party: Jenni Steinbrunner, Research Specialist, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02589964     History of Changes
Other Study ID Numbers: 13085
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study was closed due to poor recruitment, so there is no data to share.
Keywords provided by Jenni Steinbrunner, TriHealth Inc.:
probiotics
antibiotic associated diarrhea
clostridium difficile
Additional relevant MeSH terms:
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Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents