Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

NCT ID: NCT01087892

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-09-30

Brief 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.

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.

Conditions

Diarrhoea; Clostridium Difficile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Probiotic drink containing the live strain

Intervention Type: DIETARY_SUPPLEMENT

Probiotic drink contains no strain

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

Group Type: PLACEBO_COMPARATOR

placebo probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotic drink containing the live strain

Probiotic drink contains no strain

Intervention Type: DIETARY_SUPPLEMENT

placebo probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Institute International

OTHER

Sponsor Role: collaborator

University of Sussex

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chakravarthi Rajkumar

Role: STUDY_CHAIR

University of Sussex

Locations

Ashford and St Peters Hospital

Ashford, , United Kingdom

Blackpool Vicotria Hospital

Blackpool, , United Kingdom

Royal Sussex County Hospital

Brighton, , United Kingdom

Cambridge University Hospital Trust

Cambridge, , United Kingdom

Broomfield Hospital

Chelmsford, , United Kingdom

St.Richards Hospital

Chichester, , United Kingdom

Colchester Hospitals University

Colchester, , United Kingdom

Ealing Hospital

Ealing, , United Kingdom

Eastbourne District General Hospital

Eastbourne, , United Kingdom

Frimley Park Hospital

Frimley, , United Kingdom

Princess Royal Hospital

Haywards Heath, , United Kingdom

Hillingdon Hospital

Hillingdon, , United Kingdom

Lancashire Teaching Hospital

Lancaster, , United Kingdom

University Hosppitals of Leicester

Leicester, , United Kingdom

Lewisham Helathcare NHS Trust

Lewisham, , United Kingdom

Kings College Hospital

London, , United Kingdom

St Georges Hospital London

London, , United Kingdom

Queen Elizabeth Queen Mother Hospital

Margate, , United Kingdom

University Hospitals of Morecambe Bay

Morecambe, , United Kingdom

Norfolk and Norwich University

Norwich, , United Kingdom

Portsmouth Hospitals NHS Trust

Portsmouth, , United Kingdom

Worcestershire Acute Hospitals

Redditch, , United Kingdom

East Surrey Hospital

Redhill, , United Kingdom

Maidstone and Tunbridge Wells NHS Trust

Royal Tunbridge Wells, , United Kingdom

University Hospital Southampton

Southampton, , United Kingdom

Yeovil District Hospital

Yeovil, , United Kingdom

Countries

United Kingdom

Other Identifiers

UKCRN7582

Identifier Type: -

Identifier Source: org_study_id