Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection (NU278)

This study has been completed.
Sponsor:
Collaborator:
Danone Institute International
Information provided by (Responsible Party):
University of Sussex
ClinicalTrials.gov Identifier:
NCT01087892
First received: March 15, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diarrhoea
Clostridium Difficile
Dietary Supplement: Probiotic drink containing the live strain
Dietary Supplement: placebo probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by University of Sussex:

Primary Outcome Measures:
  • The incidence of diarrhoea [ Time Frame: regular intervals for 28days from entry to trial ] [ Designated as safety issue: No ]
    The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period


Secondary Outcome Measures:
  • incidence and duration of Clostridium difficile toxin [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
    The incidence and duration of Clostridium difficile toxin detected by ELISA positive testing from a stool sample taken at the onset of diarrhoea in the active and placebo groups

  • The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
    The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period

  • rate of recurrence of Clostridium difficile toxin positive diarrhoea [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
    The rate of recurrence of Clostridium difficile toxin positive diarrhoea in the active and placebo groups from hospital discharge until the end of the follow-up period

  • The quality of life in the active and placebo groups at enrollment into the study [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
  • The length of hospital stay from enrollment into the study until the end of the follow up period in the active and placebo groups The cost-effectiveness as evidenced by health economic calculations [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]

Enrollment: 1126
Study Start Date: October 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary supplement Probiotic drink

Double blind

Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days

Dietary Supplement: Probiotic drink containing the live strain
Probiotic drink contains no strain
Placebo Comparator: Dietary supplement probiotic placebo drink

Double blind

'placebo' is actually a control product

Placebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days

Dietary Supplement: placebo probiotic
Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Detailed Description:

As part of this study, we will look at both microbiological and immunological markers, in addition to analyzing the overall cost implications by analysis of health economics.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally Inclusion in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours

Exclusion Criteria:

  • Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness

Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis.

Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087892

Locations
United Kingdom
Ashford and St Peters Hospital
Ashford, United Kingdom, KT 0PZ
Blackpool Vicotria Hospital
Blackpool, United Kingdom, FY3 8NR
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Cambridge University Hospital Trust
Cambridge, United Kingdom, CB2 2QQ
Broomfield Hospital
Chelmsford, United Kingdom, CM1 7HT
St.Richards Hospital
Chichester, United Kingdom, PO19 6SE
Colchester Hospitals University
Colchester, United Kingdom, CO4 5JL
Ealing Hospital
Ealing, United Kingdom, UB1 3HW
Eastbourne District General Hospital
Eastbourne, United Kingdom, BN21 2YS
Frimley Park Hospital
Frimley, United Kingdom, SW17 7HS
Princess Royal Hospital
Haywards Heath, United Kingdom, RH16 4EX
Hillingdon Hospital
Hillingdon, United Kingdom, UB8 3NN
Lancashire Teaching Hospital
Lancaster, United Kingdom, PR2 9HT
University Hosppitals of Leicester
Leicester, United Kingdom, LE2 7LX
Lewisham Helathcare NHS Trust
Lewisham, United Kingdom, SE13 6LH
St Georges Hospital London
London, United Kingdom, SW17 0RE
Kings College Hospital
London, United Kingdom, SE5 9RS
Queen Elizabeth Queen Mother Hospital
Margate, United Kingdom, CT9 4AN
University Hospitals of Morecambe Bay
Morecambe, United Kingdom, LA1 4RP
Norfolk and Norwich University
Norwich, United Kingdom, NR4 7UY
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Worcestershire Acute Hospitals
Redditch, United Kingdom, BN8 7UB
East Surrey Hospital
Redhill, United Kingdom, RH1 5RH
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Maidstone and Tunbridge Wells NHS Trust
Tunbridge Wells, United Kingdom, ME16 9QQ
Yeovil District Hospital
Yeovil, United Kingdom, BA21 4AT
Sponsors and Collaborators
University of Sussex
Danone Institute International
Investigators
Study Chair: Chakravarthi Rajkumar University of Sussex
  More Information

No publications provided

Responsible Party: University of Sussex
ClinicalTrials.gov Identifier: NCT01087892     History of Changes
Other Study ID Numbers: UKCRN7582
Study First Received: March 15, 2010
Last Updated: July 21, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014