Official Title

Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    120
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea

in a population of general inpatients who are receiving antibiotics.
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
Study Started
Jul 31
2013
Primary Completion
Mar 31
2014
Anticipated
Study Completion
Mar 31
2014
Anticipated
Last Update
Mar 28
2014
Estimate

Dietary Supplement Theralac probiotic

Dietary Supplement Culturelle probiotic

Other placebo

Placebo Placebo Comparator

Theralac probiotic Active Comparator

Culturelle probiotic Active Comparator

Criteria

Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics.

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Exclusion Criteria:

Feeding tube in place
Pregnancy
Milk or soy allergy
Sensitivity to lactose

Immunocompromised defined as:

Absolute neutrophil count (ANC) ≤ 500 cells/mm3
HIV
Cancer patient receiving chemotherapy or radiation therapy
Immune deficiency
Post organ transplant

Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

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No Results Posted