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

Irritable Bowel Syndrome Clinical Trial

— CERAMIC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02040922
• Other study ID #: 13091
• Secondary ID: 13/EM/0310
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2014
• Last updated: May 3, 2017
• Start date: January 2013
• Est. completion date: June 2017

Study information

• Verified date: May 2017
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Campylobacter Infections
• Infection
• Intestinal Diseases
• Irritable Bowel Syndrome

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (5)

Lead Sponsor	Collaborator
University of Nottingham	Department of Health, United Kingdom, Helsinki University, King's College London, Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yes/ no: Post-Infective bowel dysfunction (PI-BD)	This will be defined by response to the question "have your bowels returned to normal since your Campylobacter infection?"	12 weeks after microbiological diagnosis of infection
Secondary	Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)	Symptoms meeting Rome III criteria for Irritable Bowel Syndrome (other than 6 month duration)	12 weeks after microbiological diagnosis of infection

External Links

•   Departmental website