NCT00973908

Brief Summary

The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

5 active sites

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 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

September 8, 2009

Last Update Submit

April 25, 2013

Conditions

Diarrhoea

Keywords

Clostridium difficile associated diarrhoeaantibiotic associated diarrhoea

Outcome Measures

Primary Outcomes (2)

  • Development of antibiotic associated diarrhoea

    28 days post last antibiotic dose

  • Development of Clostridium difficile associated diarrhoea

    28 days post last antibiotic dose

Secondary Outcomes (2)

  • Length of Hospital Stay

    28 days post last antibiotic dose

  • 30-day Mortality

    30 days after initiation of therapy

Study Arms (2)

VSL#3

ACTIVE COMPARATOR

Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

Drug: VSL#3

Placebo

PLACEBO COMPARATOR

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Drug: Placebo

Interventions

VSL#3DRUG

Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

Also known as: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus
VSL#3
PlaceboDRUG

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.

Also known as: Maltose based Placebo
Placebo

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 or older
  • Hospital inpatients
  • On systemic antibiotics for an infection
  • Antibiotics started within last 48 hours

You may not qualify if:

  • Diarrhoea at screening
  • Unable to take enteral meds
  • Patients on intensive care units
  • Severe Immunosuppression (neutropenia, AIDS, congenital immunoparesis, chemotherapy)
  • Risk of endocarditis (Artificial heart valves, history of rheumatic heart disease or infective endocarditis)
  • Regular consumption of probiotics until 1 week prior to admission
  • Acute severe pancreatitis Persistent vomiting (two days or more)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal Albert Edward Infirmary

Wigan, Lancashire, WN1 2NN, United Kingdom

Location

Queen Elizabeth Hospital

Woolwich, London, SE18 4QH, United Kingdom

Location

Frenchay Hospital

Bristol, BS16 1LE, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, BS23 4TQ, United Kingdom

Location

Related Publications (4)

  • Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4.

    PMID: 11118872BACKGROUND

  • D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.

    PMID: 12052801BACKGROUND

  • Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.

    PMID: 12182746BACKGROUND

  • Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N. Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect. 2013 Jun;84(2):159-65. doi: 10.1016/j.jhin.2013.02.019. Epub 2013 Apr 22.

    PMID: 23618760RESULT

MeSH Terms

Conditions

Diarrhea

Interventions

Lacteol

Condition Hierarchy (Ancestors)

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

Study Officials

  • Neil Haslam

    Wirghtington Wigan and Leigh NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

GB(5)