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

Primary Purpose

Post-infective Bowel Dysfunction, Functional Gastrointestinal Disorders

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
low FODMAP dietary advice
Maltodextrin
Oligofructose
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-infective Bowel Dysfunction focused on measuring FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Normal FODMAP arm

Low FODMAP arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Adequate control of IBS symptoms
Response to a yes/no question "Have your symptoms been adequately controlled?"
Adequate control of IBS symptoms
Response to a yes/no question "Have your symptoms been adequately controlled?"
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
Change from baseline in IBSS
The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders
Change from baseline in IBSS
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.
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.
Change from baseline in stool concentration of Bifidobacteria
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
Change from baseline in stool concentration of Bifidobacteria
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention

Full Information

First Posted
September 2, 2014
Last Updated
May 12, 2016
Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02232373
Brief Title
Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates
Acronym
CEDRIC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-infective Bowel Dysfunction, Functional Gastrointestinal Disorders
Keywords
FODMAPs, microbiota, oligofructose, IBS, Irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal FODMAP arm
Arm Type
Sham Comparator
Arm Description
Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.
Arm Title
Low FODMAP arm
Arm Type
Experimental
Arm Description
Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)
Intervention Type
Behavioral
Intervention Name(s)
low FODMAP dietary advice
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Dietary supplementation with maltodextrin 5 grams twice daily for a month
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligofructose
Other Intervention Name(s)
OraftiP95
Intervention Description
Dietary supplementation with oligofructose 5 grams twice daily for a month
Primary Outcome Measure Information:
Title
Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
Description
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 Outcome Measure Information:
Title
Moderate or substantial improvement in IBS symptoms
Description
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
6 months after star of diet
Title
Adequate control of IBS symptoms
Description
Response to a yes/no question "Have your symptoms been adequately controlled?"
Time Frame
1 month after start of diet
Title
Adequate control of IBS symptoms
Description
Response to a yes/no question "Have your symptoms been adequately controlled?"
Time Frame
6 months after start of diet
Title
Percentage of days with loose stool
Description
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
Title
Change from baseline in IBSS
Description
The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders
Time Frame
1 month after start of diet
Title
Change from baseline in IBSS
Time Frame
6 months after start of diet
Title
Change from baseline in fasting colonic volume
Description
This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
Time Frame
1 month after start of diet
Title
Change in fasting colonic gas volume
Description
This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
Time Frame
1 month after start of diet
Title
Change from baseline in stool concentration of Bifidobacteria
Description
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
Time Frame
1 month after start of diet
Title
Change from baseline in stool concentration of Bifidobacteria
Description
This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
Time Frame
6 months after start of diet
Other Pre-specified Outcome Measures:
Title
Change from baseline in EQ-5D-5L score
Description
The EQ5D is a validated questionnaire to measure quality of life
Time Frame
1 month after start of diet
Title
Change from baseline in EQ-5D-5L score
Time Frame
6 months after start of diet
Title
Change from baseline in stool concentration of short-chain fatty acids
Time Frame
1 month after start of diet
Title
Change from baseline in stool concentration of short-chain fatty acids
Time Frame
6 months after start of diet
Title
Change from baseline in other clades of stool microbiota
Description
This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota
Time Frame
1 month after start of diet
Title
Change from baseline in other clades of stool microbiota
Time Frame
6 months after start of diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giles AD Major, BM BCh MRCP
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin C Spiller, PhD FRCP
Organizational Affiliation
University of Nottingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.nddcbru.org.uk
Description
Departmental website

Learn more about this trial

Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

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