Clinical Trial: Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: An Observational Study of the Role of Antibiotics, Inflammation and Changes in Microbiota in the Development of Post-infective Bowel Dysfunction Following Infection With Campylobacter Jejuni or Coli

Brief Summary: The principal research objective is to determine the impact of antibiotic use on the risk of developing long term bowel symptoms after infection with the germ Campylobacter.

Detailed Summary:

The secondary research objectives are:

  • To investigate how the particular strain of the Campylobacter germ that causes the infection, and the strength of the immune response that it stimulates in the bowel, affect the risk of long term bowel symptoms.
  • To explore what changes occur after Campylobacter infection in the bacteria that usually live in the large bowel (microbiota) and the chemicals that they produce (short-chain fatty acids) when they digest nutrients. We will look for differences between people who recover fully and people who have long term bowel symptoms.

Sponsor: University of Nottingham

Current Primary Outcome: Yes/ no: Post-Infective bowel dysfunction (PI-BD) [ Time Frame: 12 weeks after microbiological diagnosis of infection ]

This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"


Original Primary Outcome: Same as current

Current Secondary Outcome: Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS) [ Time Frame: 12 weeks after microbiological diagnosis of infection ]

Symptoms meeting Rome III criteria for Irritable Bowel Syndrome (other than 6 month duration)


Original Secondary Outcome: Same as current

Information By: University of Nottingham

Dates:
Date Received: January 14, 2014
Date Started: January 2013
Date Completion: June 2017
Last Updated: May 3, 2017
Last Verified: May 2017