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NCT03223077 Clinical Trial

Mucosal and Microbiota Changes During Acute Campylobacteriosis

Irritable Bowel Syndrome Clinical Trial

Official title:
Mucosal and Microbiota Changes During Acute Campylobacteriosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03223077
Other study ID # 14-006180
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 31, 2014
Est. completion date June 2024

Study information
Verified date September 2023
Source Mayo Clinic
Contact Margaret K Breen-Lyles, BS
Phone 507-255-3520
Email Breen-Lyles.Margaret@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of IBS is the endpoint. Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection 6 months
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