Probiotics for Clostridium Difficile Infection in Older Adults (PICO)

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01680874

R03AG040669-01 (U.S. NIH Grant/Contract)

2012-0462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo