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

Sponsor

University of Nottingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT02040922

Collaborator

Nottingham University Hospitals NHS Trust (Other), Department of Health, United Kingdom (Other), King's College London (Other), University of Helsinki (Other)

450

Enrollment

Location

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Campylobacter Infections Irritable Bowel Syndrome

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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Post-Campylobacter Adults with symptoms of intestinal infection who submit a stool sample from which Campylobacter jejuni or coli is cultured

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nottingham	Nottingham		United Kingdom	NG7 2UH

Sponsors and Collaborators

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

Investigators

Study Chair: Robin C Spiller, MSc MD FRCP, University of Nottingham
Principal Investigator: Giles AD Major, BM BCh MRCP, University of Nottingham
Study Director: Mathew Diggle, MSc PhD, Nottingham University Hospitals NHS Trust
Study Director: Richard Puleston, MBBS PhD, University of Nottingham
Study Director: Miranda Lomer, PhD RD, King's College London