Funded by the National Institute of Health Research (NIHR) through its Health Technology Assessment Programme (HTA), the PLACIDE study sees a collaboration between Swansea University's School of Medicine, Abertawe Bro Morgannwg University NHS Trust and the County Durham and Darlington NHS Foundation Trust. 

Together, they aim to assess the clinical and cost effectiveness of probiotics for the deterrence of antibiotic-associated diarrhoea (AAD) and Clostridium difficile diarrhoea (CDD) in older patients, aged 65 years and over, receiving antibiotics while in hospital. 

A third of older people who are admitted to hospital require treatment with antibiotics. But, despite their unrivalled benefit, an adverse effect is that they change the 'healthy' bacteria that naturally live in the gut and, where this leads to diarrhoea with no other cause, AAD is diagnosed.  Occasionally, however, antibiotics can also lead to an overgrowth of Clostridium difficile (C. difficile).  This potentially dangerous bacterium can cause more serious diarrhoea (CDD) that may require additional treatment, including surgery, or even cause death. 

With such serious implications, and the prevalence of hospital-acquired infections continuing, the PLACIDE study is a welcome development.  Antibiotics currently result in diarrhoea in a fifth of people receiving antibiotic treatment - in effect, more than 6% of all older people admitted to hospital.
In addition to the obvious drawback of being distress caused to the patient, health care costs are increased as a result of delaying recovery from the initial illness, prolonging the length of hospital stay and additional treatment costs.  An episode of CDD has been estimated to cost the health services as much as £4,000 per case. 

From recent medical research, there is some evidence that probiotic supplements - measured doses of 'healthy' bacteria such as lactobacilli and bifidobacteria - can suppress the negative effects of antibiotics and, if taken together consistently, they could even prevent diarrhoea completely. 

With this in mind, a team of researchers from the three partner institutions plan to investigate further, running a multicentre, randomised, placebo-controlled trial across five different hospitals - Singleton Hospital and Morriston Hospital in South Wales and Darlington Memorial Hospital, University Hospital of North Durham and Bishop Auckland General Hospital in County Durham. 

Of the three-year study, lead researcher Dr Stephen Allen of Swansea University said: "We are planning to include a large number of patients admitted to different types of wards in five different hospitals in two very different NHS regions.  Our findings should help doctors working throughout the NHS to decide whether or not probiotics should be used to combat diarrhoea in those receiving antibiotics". 

Delyth Davies, Abertawe Bro Morgannwg University NHS Trust's West Division Lead Infection Control Nurse, added: "There has been a significant and continuing effort within the Trust to minimise the risks for patients in relation to CDD, and a multi-disciplinary group was established with this purpose.
"The Infection Control Team will be very interested in the findings of this new PLACIDE study.  Whilst the Trust makes every effort to minimise the risks associated with CDD, we would welcome any new evidence which indicates that probiotics may help prevent this disease for those hospitalised patients who have been prescribed antibiotics". 

Over twenty-one days, beginning during a hospital stay, the 3,000 participants will be given either the probiotic or a dummy capsule in addition to any other treatment they are already receiving.  During this time, the research team will monitor the occurrence and severity of diarrhoea, as well as quality of life, length of stay in hospital and mortality in order to assess the clinical and cost effectiveness of the treatment in deterring both AAD and CDD. 
Studying the benefits of probiotics in vulnerable groups is not unfamiliar to Swansea University's School of Medicine and its Institute of Life Science (ILS).  In recent years, Head of the School Professor Gareth Morgan, Senior Lecturer Dr Cathy Thornton and PLACIDE study leader Dr Stephen Allen, have been leading a research group dedicated to childhood immunity, particularly immune function in newborns. 

This research has yielded positive results and a trial on the effects of probiotics on immunity and the development of allergy in infants born in Swansea is on-going. 

It is hoped that the results from both of these studies will feed back into other research groups at the ILS that are dedicated to finding new solutions to old and new problems.  There is also real potential for expanding the studies to other groups at risk of infection, such as children with cystic fibrosis, and work has already begun on another clinical trial looking into the value of probiotics for reducing the risk of bacterial infections in premature babies. 

In line with the vision of the ILS to advance medical science through interdisciplinary research and innovation and turn medical research into success for both health and wealth in Wales, additional benefits of the PLACIDE study include up to ten dedicated jobs for the duration of the project.  It is also forging strong partnerships with industry as well as other NHS Trusts. 

Professor Ceri Phillips, Head of the Institute for Health Research at the School of Health Science, said "Staff at the School of Health Science will be assessing the cost effectiveness of the intervention. We will be looking at the current costs involved in managing C. difficile and the benefits from reducing the incident from occurring."

For further information about the Institute of Life Science at Swansea University, please visit the School of Medicine's website. Further information about the Abertawe Bro Morgannwg University NHS Trust is available here.