Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

University of Nottingham9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post-infective Bowel Dysfunction Functional Gastrointestinal Disorders

Interventions

low FODMAP dietary adviceBEHAVIORAL

An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.

MaltodextrinDIETARY_SUPPLEMENT

Dietary supplementation with maltodextrin 5 grams twice daily for a month

OligofructoseDIETARY_SUPPLEMENT

Dietary supplementation with oligofructose 5 grams twice daily for a month

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Nottingham

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS

The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.

Time frame: 1 month after start of diet

Secondary Outcomes

Moderate or substantial improvement in IBS symptoms

Time frame: 6 months after star of diet

Adequate control of IBS symptoms

Response to a yes/no question "Have your symptoms been adequately controlled?"

Time frame: 1 month after start of diet

Adequate control of IBS symptoms

Response to a yes/no question "Have your symptoms been adequately controlled?"

Time frame: 6 months after start of diet

Percentage of days with loose stool

Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale

Time frame: during last 14 days of dietary intervention

Change from baseline in IBSS

The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders

Data from ClinicalTrials.gov

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