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Diarrhoea | Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection

Diarrhoea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diarrhoea

Clostridium Difficile

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Probiotic drink containing the live strainProbiotic drink contains no strain

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dietary supplement Probiotic drinkDouble 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 placebo drinkDouble 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

Study Status

Completed

Start Date: October 2009

Completed Date: September 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The incidence of diarrhoea

Secondary Outcome: incidence and duration of Clostridium difficile toxin

Study sponsors, principal investigator, and references

Principal Investigator: Chakravarthi Rajkumar

Lead Sponsor: University of Sussex

Collaborator: Danone Institute International

More information:https://clinicaltrials.gov/show/NCT01087892

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