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

A Pilot Double Blind, Randomised, Placebo Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Symptoms of Post-infective Bowel Dysfunction

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 Overview

• Status: Terminated
• Conditions: Functional Gastrointestinal Disorders; Post-infective Bowel Dysfunction
• Intervention / Treatment: Behavioral: low FODMAP dietary advice; Dietary supplement: Oligofructose; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Normal FODMAP arm; Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.	Behavioral: low FODMAP dietary advice; 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.; Dietary supplement: Oligofructose; Dietary supplementation with oligofructose 5 grams twice daily for a month; Other Names: OraftiP95
EXPERIMENTAL: Low FODMAP arm; Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)	Behavioral: low FODMAP dietary advice; 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.; Dietary supplement: Maltodextrin; Dietary supplementation with maltodextrin 5 grams twice daily for a month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after start of diet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or substantial improvement in IBS symptoms	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.	6 months after star of diet
Adequate control of IBS symptoms	Response to a yes/no question "Have your symptoms been adequately controlled?"	1 month after start of diet
Adequate control of IBS symptoms	Response to a yes/no question "Have your symptoms been adequately controlled?"	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	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	1 month after start of diet
Change from baseline in IBSS		6 months after start of diet
Change from baseline in fasting colonic volume	This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.	1 month after start of diet
Change in fasting colonic gas volume	This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.	1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria	This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention	1 month after start of diet
Change from baseline in stool concentration of Bifidobacteria	This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention	6 months after start of diet

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in EQ-5D-5L score	The EQ5D is a validated questionnaire to measure quality of life	1 month after start of diet
Change from baseline in EQ-5D-5L score		6 months after start of diet
Change from baseline in stool concentration of short-chain fatty acids		1 month after start of diet
Change from baseline in stool concentration of short-chain fatty acids		6 months after start of diet
Change from baseline in other clades of stool microbiota	This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota	1 month after start of diet
Change from baseline in other clades of stool microbiota		6 months after start of diet

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: King's College London; Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Giles AD Major, BM BCh MRCP, University of Nottingham; Study Chair: Robin C Spiller, PhD FRCP, University of Nottingham

Publications and helpful links

Helpful Links

• Departmental website

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (ESTIMATE): September 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: IBS; microbiota; Irritable bowel syndrome; FODMAPs; oligofructose
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
• Other Study ID Numbers: UoN14048; 14GA012 (OTHER: Nottingham University Hospitals NHS Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO