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Probiotics for Clostridium Difficile Infection in Older Adults (PICO)

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ClinicalTrials.gov Identifier: NCT01680874
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
Duration of diarrhea [ Time Frame: 4 weeks ]
Duration of diarrhea, as indicated by a stool diary kept by the patient
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01680874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • Density of C. difficile toxin in stool [ Time Frame: 8 weeks ]
  • Stool cytokines [ Time Frame: 8 weeks ]
  • Fecal lactoferrin [ Time Frame: 8 weeks ]
  • Functional assessment using Barthel Index [ Time Frame: 8 weeks ]
  • Recurrence of CDI [ Time Frame: 8 weeks ]
    Diagnosis with a recurrent episode of C. difficile infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2012)
  • Infection with Lactobacillus [ Time Frame: 8 weeks ]
    Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures
  • Infection with Bifidobacterium [ Time Frame: 8 weeks ]
    Fever and other signs of infection with Bifidobacterium, and infection confirmed through blood cultures
Original Other Pre-specified Outcome Measures
 (submitted: September 6, 2012)
Infection with Lactobacillus [ Time Frame: 8 weeks ]
Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures
 
Descriptive Information
Brief Title  ICMJE Probiotics for Clostridium Difficile Infection in Older Adults
Official Title  ICMJE A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile
Intervention  ICMJE
  • 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
  • Dietary Supplement: Placebo
    The intervention will consist of the subject taking the placebo once a day for 4 weeks. 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.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
58
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult of either gender, 18 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
  • Is unavailable for follow-up visits
  • History of multiple C. difficile infection
  • Willing not to take other probiotics for duration of study
  • Is severely immunocompromised.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680874
Other Study ID Numbers  ICMJE 2012-0462
R03AG040669-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Nasia Safdar, MD University of Wisconsin Department of Medicine (Infectious Disease)
PRS Account University of Wisconsin, Madison
Verification Date December 2015

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