Clinical trial NCT03223077: Mucosal and Microbiota Changes During Acute Campylobacteriosis
Official title: Mucosal and Microbiota Changes During Acute Campylobacteriosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irritable Bowel Syndrome
Keywords: Post infectious
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute Campylobacter infection

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of IBS is the endpoint.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Madhusudan Grover, MBBS
role: PRINCIPAL_INVESTIGATOR
References: