NCT01680874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

September 4, 2012

Last Update Submit

December 1, 2015

Conditions

Clostridium Difficile

Keywords

Clostridium difficileDiarrheaInfectionLactobacilliBifidobacteriaLactobacillus acidophilusLactobacillus paracaseiBifidobacterium lactisYogurtProbiotics

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea

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

    4 weeks

Secondary Outcomes (5)

  • Density of C. difficile toxin in stool

    8 weeks

  • Stool cytokines

    8 weeks

  • Fecal lactoferrin

    8 weeks

  • Functional assessment using Barthel Index

    8 weeks

  • Recurrence of CDI

    8 weeks

Other Outcomes (2)

  • Infection with Lactobacillus

    8 weeks

  • Infection with Bifidobacterium

    8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

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.

Also known as: Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-07, Bifidobacterium lactis Bl-04, ATCC 700396, ATCC SD5275, ATCC SD5220, ATCC SD5219
Probiotic
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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (5)

  • 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.

    PMID: 11340528BACKGROUND

  • 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.

    PMID: 16635227BACKGROUND

  • 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.

    PMID: 19138244BACKGROUND

  • 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.

    PMID: 28961980DERIVED

  • 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.

    PMID: 26210512DERIVED

MeSH Terms

Conditions

DiarrheaInfections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Nasia Safdar, MD

    University of Wisconsin Department of Medicine (Infectious Disease)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)