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NCT Number: NCT03223077

Mucosal and Microbiota Changes During Acute Campylobacteriosis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location status: Recruiting

Location contact

Margaret K Breen-Lyles, BS

CONTACT

[email protected]

507-255-3520

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of IBS is the endpoint.

    Time frame: 6 months

    Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret K Breen-Lyles, BS

CONTACT

[email protected]

507-255-3520

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2017
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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