An Observational Study of the Role of Antibiotics, Inflammation and Changes in Microbiota in the Development of Post-infective Bowel Dysfunction Following Infection With Campylobacter Jejuni or Coli
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Campylobacter Infections
- Sponsor
- University of Nottingham
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Yes/ no: Post-Infective bowel dysfunction (PI-BD)
- Last Updated
- 9 years ago
Overview
Brief Summary
The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.
Detailed Description
The secondary research objectives are: * To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms. * To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
- •Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
- •Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
Exclusion Criteria
- •Pregnancy declared by the candidate
- •History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:
- •Inflammatory Bowel Disease
- •Coeliac Disease
- •Pancreatitis
- •Gallstone disease (biliary colic, cholecystitis)
- •Diverticulitis
- •Cancer of the gastrointestinal tract
- •Irritable Bowel Syndrome
- •Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
Outcomes
Primary Outcomes
Yes/ no: Post-Infective bowel dysfunction (PI-BD)
Time Frame: 12 weeks after microbiological diagnosis of infection
This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"
Secondary Outcomes
- Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)(12 weeks after microbiological diagnosis of infection)