Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Probiotics for Clostridium Difficile Infection in Older Adults (PICO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01680874
First received: September 4, 2012
Last updated: February 22, 2013
Last verified: February 2013

September 4, 2012
February 22, 2013
February 2013
February 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01680874 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
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
 
Probiotics for Clostridium Difficile Infection in Older Adults
A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Clostridium Difficile
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.
Other Names:
  • Lactobacillus acidophilus NCFM®
  • Lactobacillus paracasei Lpc-37
  • Bifidobacterium lactis Bi-07
  • Bifidobacterium lactis Bl-04
  • ATCC 700396
  • ATCC SD5275
  • ATCC SD5220
  • ATCC SD5219
  • Experimental: Probiotic

    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.

    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Placebo
    A placebo will be taken orally, once a day, for 4 weeks.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult of either gender, 60 years or older with a first episode of C. difficile infection
  • Meets the case definition of C. difficile infection—diarrhea associated with a positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin

Exclusion Criteria:

  • Severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm^3, elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed
  • Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
  • Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
  • Has a presence of toxic megacolon or ileus
  • Has a presence of colostomy or nasogastric tube
  • Has a history of abdominal surgery within the previous 3 months (from time of enrollment)
  • Is enrolled in another investigational drug trial
  • Has taken systemic immunosuppressive drugs within 60 days of enrollment
  • Is unavailable for follow-up visits
  • History of multiple C. difficile infection
  • Is currently taking an oral probiotic at time of enrollment
Both
60 Years and older
No
Contact: Nasia Safdar, MD 608-263-1545
Contact: Alyssa Bernardo 608-265-8224 abernardo@medicine.wisc.edu
United States
 
NCT01680874
2012-0462, R03AG040669-01
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
Principal Investigator: Nasia Safdar, MD University of Wisconsin Department of Medicine (Infectious Disease)
University of Wisconsin, Madison
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP