Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates (CEDRIC)

University of Nottingham

Status: Terminated

Conditions: Functional Gastrointestinal Disorders; Post-infective Bowel Dysfunction

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Oligofructose; Behavioral: low FODMAP dietary advice

Study type: Interventional

Funder types: Other

Identifiers

NCT02232373

UoN14048

14GA012 (Other Identifier)

Details and patient eligibility

About

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 it. In this trial the investigators will look at its effect on symptoms of people with persistent disturbance in their bowel pattern 3 months after an intestinal infection with Campylobacter.

The investigators will also look at the changes in gut bacteria that occur with the diet.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups

Normal FODMAP arm

Sham Comparator group

Description:

Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.

Treatment:

Behavioral: low FODMAP dietary advice

Dietary Supplement: Oligofructose

Low FODMAP arm

Experimental group

Description:

Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)

Treatment:

Dietary Supplement: Maltodextrin

Behavioral: low FODMAP dietary advice