Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Sponsors

Lead sponsor: University of Sussex

Collaborator: Danone Institute International

Source University of Sussex
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.

Overall Status Completed
Start Date October 2009
Completion Date September 2013
Primary Completion Date September 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The incidence of diarrhoea regular intervals for 28days from entry to trial
Secondary Outcome
Measure Time Frame
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
Enrollment 1126
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Probiotic drink containing the live strain

Description: Probiotic drink contains no strain

Arm group label: Dietary supplement Probiotic drink

Intervention type: Dietary Supplement

Intervention name: placebo probiotic

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

Arm group label: Dietary supplement probiotic placebo drink

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

Gender: All

Minimum age: 55 Years

Maximum age: N/A

Healthy volunteers: No

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

United Kingdom

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Dietary supplement Probiotic drink

Arm group type: Active Comparator

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

Arm group label: Dietary supplement probiotic placebo drink

Arm group type: Placebo Comparator

Description: 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

Acronym NU278
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov