Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

NCT01087892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1126

Last updated 2020-03-30

No results posted yet for this study

Summary

Antibiotics are currently required to treat patients in hospital when they have an infection, but these antibiotics can cause side effects such as diarrhoea and in some patients a serious form of gut infection with an organism called Clostridium difficile. This organism can produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill health, and in some circumstances can be fatal. Some studies have shown that yogurts' or Probiotics' (special drinks with a defined concentration of useful bacteria) taken by patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics use. The aim of the present study is to find out whether the use of one of these Probiotics in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium difficile infection, as well as cost saving. The study will also analyze the effects of probiotics on quality of life and length of hospital stay.

Conditions

  • Diarrhoea
  • Clostridium Difficile

Interventions

DIETARY_SUPPLEMENT

Probiotic drink containing the live strain

Probiotic drink contains no strain

DIETARY_SUPPLEMENT

placebo probiotic

Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Sponsors & Collaborators

  • Danone Institute International

    collaborator OTHER
  • University of Sussex

    lead OTHER

Principal Investigators

  • Chakravarthi Rajkumar · University of Sussex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087892 on ClinicalTrials.gov