Probiotics for Clostridium Difficile Infection in Older Adults

University of Wisconsin, Madison33 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Clostridium Difficile

Interventions

ProbioticDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Duration of diarrhea

Duration of diarrhea, as indicated by a stool diary kept by the patient

Time frame: 4 weeks

Secondary Outcomes

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

Diagnosis with a recurrent episode of C. difficile infection

Time frame: 8 weeks

Data from ClinicalTrials.gov

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