Mucosal and Microbiota Changes During Acute Campylobacteriosis

NCT03223077 | Recruiting

• 1 other identifier: 14-006180
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Post infectious

Outcome Measures

Primary Outcomes (1)

• Development of IBS is the endpoint.

  Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute Campylobacter infection

You may qualify if:

• No abdominal surgery (except appendectomy and cholecystectomy)
• Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Coded blood, stool (or other tissue) samples

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Madhusudan Grover, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret K Breen-Lyles, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: October 31, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)