Clinical trial NCT02040922: Campylobacter Enteritis and Post-Infective Bowel Dysfunction (PI-BD): Role of Antibiotics and Microbiota
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Campylobacter Infections
Irritable Bowel Syndrome
Keywords: Antibiotics
Campylobacter
Diarrhoea
Enteritis
Microbiota
Calprotectin
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
name: Department of Health, United Kingdom
name: King's College London
name: University of Helsinki
First posted: 2014-01-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Yes/ no: Post-Infective bowel dysfunction (PI-BD)
timeFrame: 12 weeks after microbiological diagnosis of infection
Secondary outcomes:
measure: Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS)
timeFrame: 12 weeks after microbiological diagnosis of infection
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Robin C Spiller, MSc MD FRCP
role: STUDY_CHAIR
affiliation: University of Nottingham
name: Giles AD Major, BM BCh MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham University Hospitals NHS Trust
name: Mathew Diggle, MSc PhD
role: STUDY_DIRECTOR
affiliation: University of Nottingham
name: Richard Puleston, MBBS PhD
role: STUDY_DIRECTOR
affiliation: King's College London
name: Miranda Lomer, PhD RD
role: STUDY_DIRECTOR
References:
citation: 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.