Role of Clostridium difficile in infant diarrhoea Version 1.0

• Research type

  Research Study

• Full title

  Impact of Clostridium difficile on clinical outcomes in hospitalised infants with diarrhoea (CD-COT)

• IRAS ID

  265519

• Contact name

  Jane Freeman

• Contact email

  jane.freeman4@nhs.net

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  What is the impact of Clostridium difficile on clinical outcomes in hospitalised infants with diarrhoea?
  Clostridium difficile is a bacterium that causes diarrhoea, particularly in elderly hospitalised patients on antibiotics. C. difficile infection (CDI) arises when antibiotics affect the good bacteria in our guts, allowing C. difficile to move in, grow and produce toxins (poisons) that result in diarrhoea. Hospitals diagnose (CDI) by detecting the toxin in faeces (poo).
  We know lots about CDI in adults, but we don't yet understand what the presence of C. difficile toxin in infant (<1yr) diarrhoeal faeces means. Because of this, current UK guidelines discourage testing in infants meaning that healthcare professionals don't have any rules to guide them on when to test for C. difficile toxin in these patients.

  This 2 year study will determine if C. difficile toxin present in infant diarrhoeal faeces contributes to diarrhoea symptoms or not. We will look for C. difficile toxin in all infant diarrhoeal faeces sent to the routine diagnostic laboratory in four teaching hospitals. We will compare how quickly diarrhoea gets better in infants WITH toxin compared to those WITHOUT toxin in their faeces, to tell us whether C. difficile toxin is contributing to the diarrhoea. We will examine patient notes to see if other factors (eg an underlying condition, other treatments, breast or bottle feeding) are linked to infants having toxin in their diarrhoeal faeces and those who do not get better as quickly. This will help us to know which infants should be tested for C. difficile toxin. The C. difficile bacteria we recover will be DNA fingerprinted and tested for antibiotic resistance.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  20/YH/0084

• Date of REC Opinion

  19 Mar 2020

• REC opinion

  Favourable Opinion