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Probiotics for Clostridium Difficile Infection in Older Adults (PICO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680874
First Posted: September 7, 2012
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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 Dietary Supplement: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile

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

Primary Outcome Measures:
  • Duration of diarrhea [ Time Frame: 4 weeks ]
    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 ]
  • 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


Other Outcome Measures:
  • 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


Enrollment: 33
Study Start Date: February 2013
Study Completion Date: February 2015
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.
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680874


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
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 ( U.S. NIH Grant/Contract )
First Submitted: September 4, 2012
First Posted: September 7, 2012
Last Update Posted: December 3, 2015
Last Verified: December 2015

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