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Probiotics for Clostridium Difficile Infection in Older Adults (PICO)

This study is currently recruiting participants.
Verified February 2013 by University of Wisconsin, Madison
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile
 Dietary Supplement: Probiotic
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 58
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)
Arms Assigned Interventions
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.

 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
Placebo Comparator: Placebo
A placebo will be taken orally, once a day, for 4 weeks.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680874

Contacts
Contact: Nasia Safdar, MD 608-263-1545
Contact: Alyssa Bernardo 608-265-8224 abernardo@medicine.wisc.edu

Locations
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     abernardo@medicine.wisc.edu    
Principal Investigator: Nasia Safdar, MD            
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Nasia Safdar, MD University of Wisconsin Department of Medicine (Infectious Disease)
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01680874     History of Changes
Other Study ID Numbers: 2012-0462, R03AG040669-01
Study First Received: September 4, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Clostridium difficile
Diarrhea
Infection
Lactobacilli
Bifidobacteria
 Lactobacillus acidophilus
Lactobacillus paracasei
Bifidobacterium lactis
Yogurt
Probiotics

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013