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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02040922
Other study ID # 13091
Secondary ID 13/EM/0310
Status Active, not recruiting
Phase N/A
First received January 14, 2014
Last updated May 3, 2017
Start date January 2013
Est. completion date June 2017

Study information

Verified date May 2017
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date June 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United Kingdom University of Nottingham Nottingham

Sponsors (5)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes/ No: Post-Infective irritable bowel syndrome (PI-IBS) Symptoms meeting Rome III criteria for Irritable Bowel Syndrome (other than 6 month duration) 12 weeks after microbiological diagnosis of infection
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