Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03223077

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Irritable Bowel Syndrome

Study ID

NCT03223077

Start date

Oct 31, 2014

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Development of IBS is the endpoint. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Margaret K Breen-Lyles, BS

507-255-3520Breen-Lyles.Margaret@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Margaret K Breen-Lyles, BS

507-255-3520Breen-Lyles.Margaret@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Post infectious

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-07.