Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
...
Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
Age ≥ 18

Exclusion Criteria

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
Cancer of the gastrointestinal tract
Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection.
...
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
Cancer of the gastrointestinal tract
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
Irritable Bowel Syndrome
Pancreatitis
Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding
Gallstone disease (biliary colic, cholecystitis)
Use of antibiotics in the preceding four weeks other than for treatment of index infection.
Pregnancy declared by the candidate
Coeliac Disease
Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
Intestinal stoma
Inflammatory Bowel Disease
Declared participation in any medical trials in the past 3 months
Diverticulitis

Summary

Conditions
  • Campylobacter Infections
  • Irritable Bowel Syndrome
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Inclusion Criteria

Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
...
Submission of stool sample to Nottingham University Hospitals Microbiology Laboratory for investigation of these symptoms
Clinical syndrome suggestive of intestinal infection, including symptoms such as new onset of abdominal pain, vomiting, diarrhoea, blood in stools, fever
Campylobacter sp. cultured by selective media (standard clinical practice) from this stool sample
Age ≥ 18

Exclusion Criteria

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
Cancer of the gastrointestinal tract
Use of purgative products/ high dose laxatives for bowel preparation in the four weeks prior to index infection.
...
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
Cancer of the gastrointestinal tract
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
Irritable Bowel Syndrome
Pancreatitis
Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
Inability to complete the symptom questionnaires e.g. cognitive dysfunction limiting memory and understanding
Gallstone disease (biliary colic, cholecystitis)
Use of antibiotics in the preceding four weeks other than for treatment of index infection.
Pregnancy declared by the candidate
Coeliac Disease
Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
Intestinal stoma
Inflammatory Bowel Disease
Declared participation in any medical trials in the past 3 months
Diverticulitis

Tracking Information

NCT #
NCT02040922
Collaborators
  • 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
  • Study Chair: Robin C Spiller, MSc MD FRCP University of Nottingham 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
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