NCT02040922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

January 14, 2014

Last Update Submit

May 3, 2017

Conditions

Campylobacter InfectionsIrritable Bowel Syndrome

Keywords

AntibioticsCampylobacterDiarrhoeaEnteritisMicrobiotaCalprotectin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)

    12 weeks after microbiological diagnosis of infection

Study Arms (1)

Post-Campylobacter

Adults with symptoms of intestinal infection who submit a stool sample from which Campylobacter jejuni or coli is cultured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • Jalanka J, Gunn D, Singh G, Krishnasamy S, Lingaya M, Crispie F, Finnegan L, Cotter P, James L, Nowak A, Major G, Spiller RC. Postinfective bowel dysfunction following Campylobacter enteritis is characterised by reduced microbiota diversity and impaired microbiota recovery. Gut. 2023 Mar;72(3):451-459. doi: 10.1136/gutjnl-2021-326828. Epub 2022 Sep 28.

    PMID: 36171082DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Stool (Faeces) Whole Blood

MeSH Terms

Conditions

Campylobacter InfectionsIrritable Bowel SyndromeDiarrheaEnteritis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastroenteritis

Study Officials

  • Robin C Spiller, MSc MD FRCP

    University of Nottingham

    STUDY CHAIR

  • Giles AD Major, BM BCh MRCP

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 20, 2014

Study Start

January 1, 2013

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)