Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Clostridium Difficile Clinical Trial

— NU278  

Official title:

Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087892
• Other study ID #: UKCRN7582
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: September 2013

Study information

• Verified date: March 2020
• Source: University of Sussex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1126
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Diarrhea
• Diarrhoea

Intervention

Dietary Supplement:
• Probiotic drink containing the live strain
Probiotic drink contains no strain
• placebo probiotic
Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Locations

Country	Name	City	State
United Kingdom	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	University Hospital Southampton	Southampton
United Kingdom	Maidstone and Tunbridge Wells NHS Trust	Tunbridge Wells
United Kingdom	Yeovil District Hospital	Yeovil

Sponsors (2)

Lead Sponsor	Collaborator
University of Sussex	Danone Institute International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence and duration of Clostridium difficile toxin	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	regular intervals for 28 days from entry to trial
Secondary	The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period	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
Secondary	rate of recurrence of Clostridium difficile toxin positive diarrhoea	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	regular intervals for 28 days from entry to trial
Secondary	The quality of life in the active and placebo groups at enrollment into the study		regular intervals for 28 days from entry to trial
Secondary	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