Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are doing this study to understand if changes in gut bacteria and gut mucosal lining during an acute infection can help identify individuals who might be at risk for developing problems in the future.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 30, 2022
Gastrointestinal (GI) infections involving a variety of bacterial, viral, and parasitic pathogens predispose patients to post-infectious irritable bowel syndrome (PI-IBS) and other functional GI disorders1. Campylobacter is one of the top five organisms responsible for food-borne illnesses causing approximately 0.8 million cases annually2. Isolated C. jejuni infection has been associated with a PI-IBS risk of 9% to 13%3. Epidemiological studies have identified female gender, age <60 years, smoking, enteritis severity, and pre-enteritis psychological stress as risk-factors for development of PI-IBS4. In a single study, variants in host genes TLR9, IL6, and CDH1 were identified as independent risk factors for development of PI-IBS after controlling for previously identified clinical risk factors5. In another study, host cytokines were looked at in relation to development of reactive arthritis and IBS following Campylobacter enteritis. The risk of acquiring clinical gastroenteritis with Campylobacter jejuni/coli was related to the INFG (+ 874A>T) of intron 1. Polymorphisms in IL-18 and INFG were linked to the risk of post-infectious reactive arthritis, but not to PI-IBS6. However, this study was limited by assessment of only serum cytokine profile and not mucosal. A recent study has shown that fecal microbiota of patients with PI-IBS differs from that of healthy controls and resembles that of patients with IBS with diarrhea (IBS-D)7. The microbiota is altered during acute enteritis, but it is unclear if there are any signatures in acute microbiota alterations that can help predict development of PI-IBS following Campylobacter enteritis. Our overall goal with this study is to identify non-invasive and invasive host factors that can help predict the development of PI-IBS following Campylobacter enteritis.
Arms, Groups and Cohorts
- Acute Campylobacter
- We will enroll 150 patients with acute Campylobacter infection. Our microbiology laboratory will inform us of a culture or PCR positive case of Campylobacter infection as soon as that test result is available.
Clinical Trial Outcome Measures
- Development of IBS is the endpoint.
- Time Frame: 6 months
- Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection
Participating in This Clinical Trial
- No abdominal surgery (except appendectomy and cholecystectomy) – Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter Exclusion Criteria:
- History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease. – History of gastroenteritis in six months prior to Campylobacter enteritis – Pregnancy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Mayo Clinic
- Provider of Information About this Clinical Study
- Principal Investigator: Madhusudan (Madhu) Grover, MBBS, Principal Investigator – Mayo Clinic
- Overall Official(s)
- Madhusudan Grover, MBBS, Principal Investigator, Mayo Clinic
- Overall Contact(s)
- Margaret K Breen-Lyles, BS, 507-255-3520, Breen-Lyles.Margaret@mayo.edu
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