None listed
Conditions
Brief summary
Colonic spirochaetosis (CS) was first described in humans in 1967. The role of CS in human health and disease has been debated in the literature and historically it was considered to be a commensal organism. Recent studies have shown that CS is associated with abdominal pain and diarrhoea in multiple population samples and that CS is associated with subtle but clinically significant submucosal eosinophilia. This supports the hypothesis that CS is a pathologic finding that should be considered in cases of diarrhoea predominant irritable bowel syndrome (IBS-d). Despite this there is no clear treatment recommendation for CS. CS prevalence in developed countries is estimated to be 2-7%. Furthermore, the risk of IBS-d symptoms in patients with CS is three fold. In western populations the prevalence of the irritable bowel syndrome is 7-16%. If a conservative estimate is taken it is possible that 2% of the general population is infected with CS and experiences potentially treatable symptoms of IBS-d that have a significant personal and economic costs. Our research question follows on from this to ask whether treating CS in patients with IBS-d will lead to an improvement in symptoms. This question has not been adequately answered in a prospective high quality trial. A positive result would demand confirmation and further trials to estimate sustainability of the effect. This has the potential to change the diagnostic and treatment algorithm for IBS and affect a substantial number of people. It is interesting to note that metronidazole is used to empirically treat chronic diarrhoea in the community with anecdotal benefit and this may represent unknowing treatment of CS.
Interventions
Metronidazole 400mg orally three times daily for ten days.
Adherence will be monitored through tablet return and count at the scheduled end of treatment review.
Sponsors
PRC Digestive Health and Neurogastroenterology fund through the Hunter Medical Research Institute in conjunction witht he University of Newcaslte
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age > 18 years • Able to consent • Clear diagnosis of IBD-d in the medical record with adequate exclusion of other causes. This includes duration of symptoms for more than 3 months, stool culture for exclusion of common causes of chronic diarrhoea including parasitic infection with stool microbiology, malabsorption based on clinical impression with appropriate investigations or bile acid diarrhoea. • Willingness to submit stool samples and take metronidazole. • No metronidazole taken in the last 6 months. • Not have an alcohol dependence disorder due to risk of disulfram like reaction with metronidazole. • No other long term antibiotic use. • No immunodeficiency (HIV, Long term steroid use, use of immunosuppressive agents) • Not be pregnant or have a chance of falling pregnant whilst taking treatment
Exclusion criteria
Unable to consent Immunodeficiency Pregnancy Inflammatory bowel disease Antibiotic use in last 6 months
Outcome results
None listed