Official Title
Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
Phase
N/ALead Sponsor
University of Alabama, BirminghamStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Development of Clostridium Difficile Associated DiarrheaIntervention/Treatment
autologous microbiome lactobacillus rhamnosus ...Study Participants
120We 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.
Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics. - 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Cancer patient receiving chemotherapy or radiation therapy Immune deficiency Post organ transplant Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization. -
