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Trial record 2 of 3 for:    Recruiting, Not yet recruiting, Available Studies | "Campylobacter Infections"

Mucosal and Microbiota Changes During Acute Campylobacteriosis

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ClinicalTrials.gov Identifier: NCT03223077
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Madhusudan (Madhu) Grover, MBBS, Mayo Clinic

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.

Condition or disease
Irritable Bowel Syndrome

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.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mucosal and Microbiota Changes During Acute Campylobacteriosis
Actual Study Start Date : October 31, 2014
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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 Measures :
  1. Development of IBS is the endpoint. [ Time Frame: 6 months ]
    Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection


Biospecimen Retention:   Samples With DNA
Coded blood, stool (or other tissue) samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute Campylobacter infection
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223077


Contacts
Contact: Wendy J Sundt, BS 507-293-4234 sundt.wendy@mayo.edu
Contact: Margaret K Breen-Lyles, BS 507-255-3520 Breen-Lyles.Margaret@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Wendy J Sundt, BS    507-293-4234    sundt.wendy@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Madhusudan Grover, MBBS Mayo Clinic

Responsible Party: Madhusudan (Madhu) Grover, MBBS, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03223077     History of Changes
Other Study ID Numbers: 14-006180
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Madhusudan (Madhu) Grover, MBBS, Mayo Clinic:
Post infectious

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Campylobacter Infections
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections