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

• Conditions: Irritable Bowel Syndrome; Campylobacter Infections

• Registration Number: NCT02040922
• Lead Sponsor: University of Nottingham

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 Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Primary Completion: 2017-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age ≥ 18
• Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
• Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
• Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample

Exclusion Criteria

• Pregnancy declared by the candidate

• History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to:

  • Inflammatory Bowel Disease
  • Coeliac Disease
  • Pancreatitis
  • Gallstone disease (biliary colic, cholecystitis)
  • Diverticulitis
  • Cancer of the gastrointestinal tract
  • Irritable Bowel Syndrome

• Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder

• Intestinal stoma

• Habitual use of opiate analgesics likely to alter bowel function e.g. morphine

• Use of antibiotics in the preceding four weeks other than for treatment of index infection.

• Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection.

• Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration

• Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding

• Declared participation in any medical trials in the past 3 months

• Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yes/ no: Post-Infective bowel dysfunction (PI-BD)	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?"

Secondary Outcome Measures

Name	Time	Method
Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)	12 weeks after microbiological diagnosis of infection	Symptoms meeting Rome III criteria for Irritable Bowel Syndrome (other than 6 month duration)

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, United Kingdom