Status:
TERMINATED
Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
King's College London
Conditions:
Post-infective Bowel Dysfunction
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare...
Eligibility Criteria
Inclusion
- Participation in the CERAMIC study (see linked protocol)
- On-going post infective bowel dysfunction (PI-BD) 3 months after confirmation of Campylobacter spp. in stool sample. This is defined as responding 'No' to the question "have your bowels returned to normal since your Campylobacter infection?"
- Will consent to use of data and samples acquired for CERAMIC in the analysis of CEDRIC
Exclusion
- As for CERAMIC study (so already confirmed)
- 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. 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
- 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
- Addition criteria for CEDRIC study:
- Use of antibiotics or prescribed probiotics during the CERAMIC study
- Failure to provide research stool samples during CERAMIC study
- Dietary practice not compatible with safe implementation of the trial diet e.g.veganism
- Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g. end-stage kidney disease, diabetes
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02232373
Start Date
August 1 2014
End Date
August 1 2015
Last Update
May 13 2016
Active Locations (1)
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1
University of Nottingham
Nottingham, United Kingdom, NG7 2UH