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

University of Nottingham

Status: Unknown

Conditions: Irritable Bowel Syndrome; Campylobacter Infections

Study type: Observational

Funder types: Other

Identifiers

NCT02040922

13/EM/0310 (Other Identifier)

13091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

450 participants in 1 patient group

Post-Campylobacter

Description:

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