Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

NCT01087892 | Completed DMC

• 1 other identifier: UKCRN7582
• Study Type: interventional
• Target: 1,126
• Locations: 1 country
• Sites: 26

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.

Conditions

Diarrhoea; Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• The incidence of diarrhoea

  The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period

  regular intervals for 28days from entry to trial

Secondary Outcomes (5)

• incidence and duration of Clostridium difficile toxin

  regular intervals for 28 days from entry to trial

• The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period

  regular intervals for 28 days from entry to trial

• rate of recurrence of Clostridium difficile toxin positive diarrhoea

  regular intervals for 28 days from entry to trial

• The quality of life in the active and placebo groups at enrollment into the study

  regular intervals for 28 days from entry to trial

• 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

  regular intervals for 28 days from entry to trial

Study Arms (2)

Dietary supplement Probiotic drink

ACTIVE COMPARATOR

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

Dietary supplement probiotic placebo drink

PLACEBO COMPARATOR

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

Interventions

Probiotic drink containing the live strain DIETARY_SUPPLEMENT

Probiotic drink contains no strain

Dietary supplement Probiotic drink

placebo probiotic DIETARY_SUPPLEMENT

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

Dietary supplement probiotic placebo drink

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sussex: lead
• Danone Institute International: collaborator

Study Sites (26)

Ashford and St Peters Hospital

Ashford, KT 0PZ, United Kingdom

Location

Blackpool Vicotria Hospital

Blackpool, FY3 8NR, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Cambridge University Hospital Trust

Cambridge, CB2 2QQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, CM1 7HT, United Kingdom

Location

St.Richards Hospital

Chichester, PO19 6SE, United Kingdom

Location

Colchester Hospitals University

Colchester, CO4 5JL, United Kingdom

Location

Ealing Hospital

Ealing, UB1 3HW, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, BN21 2YS, United Kingdom

Location

Frimley Park Hospital

Frimley, SW17 7HS, United Kingdom

Location

Princess Royal Hospital

Haywards Heath, RH16 4EX, United Kingdom

Location

Hillingdon Hospital

Hillingdon, UB8 3NN, United Kingdom

Location

Lancashire Teaching Hospital

Lancaster, PR2 9HT, United Kingdom

Location

University Hosppitals of Leicester

Leicester, LE2 7LX, United Kingdom

Location

Lewisham Helathcare NHS Trust

Lewisham, SE13 6LH, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

St Georges Hospital London

London, SW17 0RE, United Kingdom

Location

Queen Elizabeth Queen Mother Hospital

Margate, CT9 4AN, United Kingdom

Location

University Hospitals of Morecambe Bay

Morecambe, LA1 4RP, United Kingdom

Location

Norfolk and Norwich University

Norwich, NR4 7UY, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Worcestershire Acute Hospitals

Redditch, BN8 7UB, United Kingdom

Location

East Surrey Hospital

Redhill, RH1 5RH, United Kingdom

Location

Maidstone and Tunbridge Wells NHS Trust

Royal Tunbridge Wells, ME16 9QQ, United Kingdom

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

Yeovil District Hospital

Yeovil, BA21 4AT, United Kingdom

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chakravarthi Rajkumar

  University of Sussex

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

GB (26)