Gastric Juice, Nitrite and C. Diff
Research type
Research Study
Full title
The interaction between gastric acidity and nitrite content on its bactericidal activity towards Clostridium Difficile
IRAS ID
201935
Contact name
Stephen Lewis
Contact email
Sponsor organisation
Plymouth Hospitals NHS Trust, Research Office
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Clostridium Difficile (CD) is a bacterium that can be asymptomatic, uncomplicated diarrhoea or inflammation of the bowel, with the elderly being the most vulnerable. The latter can lead to significant mortality and morbidity. It is known that proton pump inhibitors, e.g. omeprazole, can inhibit the production of gastric acid and thus increase the chances of getting CD diarrhoea. It is also known that nitrate from the Western diet can also contribute to the antimicrobial properties of killing CD in the gut. We would like to find out how CD thrives in various conditions with both vegetative and spore forms of CD. Previous studies have been limited to the laboratory and if this study were to demonstrate a significant effect of nitrate against CD, it could provide justification for a clinical trial.
The study is a cross-over multiple armed study, i.e. three arms in which each of the participants is given all the study treatments in successive periods. We would invite healthy volunteers between the ages of 18 and 25 from a single centre to take part in the study. They will be asked to undergo three separate collections of gastric juice in a random order after either no study drug, co-amoxiclav for 3 days or omeprazole for 3 days. A fine bore feeding nasogastric tube will then be inserted to collect samples. The ability of CD to survive after incubation in the gastric juice will be measured and compared to baseline.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0142
Date of REC Opinion
31 May 2016
REC opinion
Favourable Opinion