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

Mucosal and Microbiota Changes During Acute Campylobacteriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03223077
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
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

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



Primary Outcome Measures :
  1. Number of Subjects Who Develop Irritable Bowel Syndrome After Campylobacter Infection [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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: Elizabeth P Abrahamson, BA 507-538-9898 abrahamson.elizabeth@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: July 19, 2017
Last Verified: July 2017
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

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