Probiotics for Clostridium Difficile Infection in Older Adults

Clostridium Difficile Clinical Trial

— PICO  

Official title:

A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680874
• Other study ID #: 2012-0462
• Secondary ID: R03AG040669-01
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2012
• Last updated: December 1, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2001 May 4. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infection with Lactobacillus	Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures	8 weeks	Yes
Other	Infection with Bifidobacterium	Fever and other signs of infection with Bifidobacterium, and infection confirmed through blood cultures	8 weeks	Yes
Primary	Duration of diarrhea	Duration of diarrhea, as indicated by a stool diary kept by the patient	4 weeks	No
Secondary	Density of C. difficile toxin in stool		8 weeks	No
Secondary	Stool cytokines		8 weeks	No
Secondary	Fecal lactoferrin		8 weeks	No
Secondary	Functional assessment using Barthel Index		8 weeks	No
Secondary	Recurrence of CDI	Diagnosis with a recurrent episode of C. difficile infection	8 weeks	No