Probiotics for Clostridium Difficile Infection in Older Adults (PICO)
The purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode of C. difficile infection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile|
- Duration of diarrhea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Duration of diarrhea, as indicated by a stool diary kept by the patient
- Density of C. difficile toxin in stool [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Stool cytokines [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Fecal lactoferrin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Functional assessment using Barthel Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Recurrence of CDI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Diagnosis with a recurrent episode of C. difficile infection
- Infection with Lactobacillus [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures
- Infection with Bifidobacterium [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Fever and other signs of infection with Bifidobacterium, and infection confirmed through blood cultures
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
This arm will receive a probiotic combination which will consist of equal amounts of Lactobacillus acidophilus NCFM® (ATCC 700396), Lactobacillus paracasei Lpc-37 (ATCC SD5275), Bifidobacterium lactis Bi-07 (ATCC SC5220), and Bifidobacterium lactis Bl-04 (ATCC SD5219).
The probiotic will be taken orally, once a week, for 4 weeks.
Dietary Supplement: Probiotic
The intervention will consist of the subject taking the study medication once a day for 4 weeks. During hospitalization, patients will be followed daily for diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. Upon discharge from the hospital, patients will be contacted through weekly phone calls to assess diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. At weeks 4 and 8, a stool sample will be collected, and the stool diary will be reviewed.
Placebo Comparator: Placebo
A placebo will be taken orally, once a day, for 4 weeks.
Probiotics are live microorganisms that are available over the counter, widely used as dietary supplements or nutritional foods, and represent a low-cost, well tolerated, safe, non-antibiotic based strategy that may have efficacy as adjunctive treatment of infections without the attendant risks of promoting antimicrobial resistance. Certain probiotics have demonstrated inhibition of adherence of pathogenic bacteria and stimulation of systemic immune functions, possibly enhancing the body's ability to eradicate C. difficile in the gastrointestinal tract. However, limited data is available on the efficacy of probiotics for ameliorating C. difficile symptoms and reducing recurrence of C. difficile infection (CDI). The investigators propose a pilot randomized, double-blind, placebo-controlled clinical trial in older adult inpatients with a first episode of CDI to evaluate the efficacy of a probiotic combination, in conjunction with standard treatment, for reducing duration of diarrhea and recurrence of CDI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680874
|Contact: Nasia Safdar, MD||608-263-1545|
|Contact: Alyssa Bernardofirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Nasia Safdar, MD 608-263-1545|
|Contact: Alyssa Bernardo 608-265-8224 email@example.com|
|Principal Investigator: Nasia Safdar, MD|
|Principal Investigator:||Nasia Safdar, MD||University of Wisconsin Department of Medicine (Infectious Disease)|