- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680874
Probiotics for Clostridium Difficile Infection in Older Adults (PICO)
December 1, 2015 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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:
|
Placebo Comparator: Placebo
A placebo will be taken orally, once a day, for 4 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of diarrhea
Time Frame: 4 weeks
|
Duration of diarrhea, as indicated by a stool diary kept by the patient
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Density of C. difficile toxin in stool
Time Frame: 8 weeks
|
8 weeks
|
|
Stool cytokines
Time Frame: 8 weeks
|
8 weeks
|
|
Fecal lactoferrin
Time Frame: 8 weeks
|
8 weeks
|
|
Functional assessment using Barthel Index
Time Frame: 8 weeks
|
8 weeks
|
|
Recurrence of CDI
Time Frame: 8 weeks
|
Diagnosis with a recurrent episode of C. difficile infection
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection with Lactobacillus
Time Frame: 8 weeks
|
Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures
|
8 weeks
|
Infection with Bifidobacterium
Time Frame: 8 weeks
|
Fever and other signs of infection with Bifidobacterium, and infection confirmed through blood cultures
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nasia Safdar, MD, University of Wisconsin Department of Medicine (Infectious Disease)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alvarez-Olmos MI, Oberhelman RA. Probiotic agents and infectious diseases: a modern perspective on a traditional therapy. Clin Infect Dis. 2001 Jun 1;32(11):1567-76. doi: 10.1086/320518. Epub 2001 May 4.
- McFarland LV. Meta-analysis of probiotics for the prevention of antibiotic associated diarrhea and the treatment of Clostridium difficile disease. Am J Gastroenterol. 2006 Apr;101(4):812-22. doi: 10.1111/j.1572-0241.2006.00465.x.
- Safdar N, Barigala R, Said A, McKinley L. Feasibility and tolerability of probiotics for prevention of antibiotic-associated diarrhoea in hospitalized US military veterans. J Clin Pharm Ther. 2008 Dec;33(6):663-8. doi: 10.1111/j.1365-2710.2008.00980.x.
- Barker AK, Duster M, Valentine S, Hess T, Archbald-Pannone L, Guerrant R, Safdar N. A randomized controlled trial of probiotics for Clostridium difficile infection in adults (PICO). J Antimicrob Chemother. 2017 Nov 1;72(11):3177-3180. doi: 10.1093/jac/dkx254.
- Barker A, Duster M, Valentine S, Archbald-Pannone L, Guerrant R, Safdar N. Probiotics for Clostridium difficile infection in adults (PICO): Study protocol for a double-blind, randomized controlled trial. Contemp Clin Trials. 2015 Sep;44:26-32. doi: 10.1016/j.cct.2015.07.015. Epub 2015 Jul 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
September 4, 2012
First Submitted That Met QC Criteria
September 6, 2012
First Posted (Estimate)
September 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-0462
- R03AG040669-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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