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

May 3, 2017 updated by: University of Nottingham

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults in the Nottinghamshire area with no previous history of gastrointestinal disorder or surgical resection. Those who submit a stoo lsample from which Campylobacter spp. is cultured will be invited to take part.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
12 weeks after microbiological diagnosis of infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks after microbiological diagnosis of infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13091
  • 13/EM/0310 (OTHER: National Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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