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Carbohydrate Reduction and Impact on Gastrointestinal System (CRAIGS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Low FODMAP Diet
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring FODMAPs, Low FODMAP Diet

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 and above
  • Able to give informed consent
  • Previous Diagnosis of IBS by medical practitioner
  • Meeting ROME III criteria for IBS
  • Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
  • Full blood count test does not indicate Anaemia

Exclusion Criteria:

  • Inclusion

    • Aged 18 and above
    • Able to give informed consent
    • Previous Diagnosis of IBS by medical practitioner
    • Meeting ROME III criteria for IBS
    • Investigations showing negative tissue transglutaminase (tTG) IgA antibodies
    • Full blood count test does not indicate Anaemia

Exclusion

  • Children (<18 years)

  • 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
  • Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
  • Intestinal stoma
  • Limited understanding of English
  • Pregnancy declared by the candidate
  • Red flag symptoms such as rectal bleeding, family history of bowel or ovarian cancer, a change in bowel habit to looser and/or more frequent stools persisting for more than six weeks in a person aged over 60 years.
  • Investigations showing positive tissue transglutaminase (tTG) IgA antibodies
  • Anaemia confirmed by full blood count test
  • 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. chaotic lifestyle related to substance abuse
  • 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
  • Participants taking prebiotic/probiotic

Sites / Locations

  • Nottingham Digestive Diseases Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immediate Intervention

Delayed Intervention

Arm Description

Participants in this arm will receive an immediate low FODMAP dietary intervention on their second visit after they have been screened, consented and enrolled during visit 1.

Participants in this arm will receive a delayed Low FODMAP dietary intervention during their third visit after they have been been screened, consented and enrolled during visit 1.

Outcomes

Primary Outcome Measures

Adequate symptom relief between cases and controls
Adequate symptom relief assessed by questionnaire after intervention in cases and before intervention in cases

Secondary Outcome Measures

Changes in colonic volume between cases and controls from baseline
A change in colonic volume measured in milliliters (ml) from baseline and after intervention in cases. This will compared with a change in colonic volume from baseline and before intervention in controls.
Changes in fermentation between cases and controls
A change in breath hydrogen concentration measured in parts per million (ppm) from: baseline and after intervention (cases) ii) from baseline and before intervention (controls)

Full Information

First Posted
August 18, 2017
Last Updated
November 1, 2018
Sponsor
University of Nottingham
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03729622
Brief Title
Carbohydrate Reduction and Impact on Gastrointestinal System
Acronym
CRAIGS
Official Title
A Pilot Randomised Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Gastrointestinal Form and Symptoms in Irritable Bowel Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Title : A pilot single blind randomised controlled trial of the effect of a diet low in poorly digested carbohydrates on gastrointestinal form and symptoms in irritable bowel syndrome patients Acronym: CRAIGS Short title: Carbohydrate reduction and impact on gastrointestinal system Chief Investigator: Prof Robin Spiller Objectives: The purpose of this study is to: Investigate the proportion of patients with Irritable Bowel Syndrome who report moderate or substantial improvement in their symptoms after 2 weeks of following a diet low in Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs) compared to patients who are on their habitual diet. Determine the difference in colonic volume of IBS patients receiving immediate low FODMAP dietary intervention after 2 weeks compared to patients who are not on the diet (delayed dietary intervention). Investigate the changes in self-reported food intolerance that occurs before dietary intervention. Trial Configuration: 2-arm, parallel group, randomised, controlled trial Setting : Research clinic within NIHR Biomedical Research Unit, Secondary care
Detailed Description
TRIAL / STUDY OBJECTIVES AND PURPOSE The trial aims to investigate the effect of a diet low in FODMAPs on colonic morphology as well as in improving symptoms of irritable bowel syndrome (IBS). This mechanistic information, along with the clinical data, will allow planning of larger, multi-centre studies of the low FODMAP diet in similar patients. HYPOTHESES Patients on a low FODMAP diet for 2 weeks will have a decreased fasting colonic volume measured by Magnetic Resonance Imaging (MRI) compared to participants who have not started the diet. Patients with IBS are more likely to report a clinically important improvement in symptoms following the low FODMAP diet (immediate intervention) compared to those on their habitual diet (delayed intervention). PRIMARY OBJECTIVE • To compare the proportion of IBS patients reporting a clinically important improvement in symptoms following a low FODMAP diet for 2 weeks against IBS patients who are on their habitual diet. SECONDARY OBJECTIVES • Determine the difference in fasting colonic volume of IBS patients receiving low FODMAP dietary intervention after 2 weeks compared to those on habitual diet. TRIAL DESIGN This will be a pilot single-blind, randomised, controlled trial (RCT). Since some activity will take place on the University of Nottingham this will be a multi-centre study. All participants will receive advice from a dietitian on the low FODMAP diet. They will be randomised to one of two parallel treatment arms: Low FODMAP dietary advice (immediate intervention) Habitual diet (control - delayed intervention )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
FODMAPs, Low FODMAP Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive an immediate low FODMAP dietary intervention on their second visit after they have been screened, consented and enrolled during visit 1.
Arm Title
Delayed Intervention
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a delayed Low FODMAP dietary intervention during their third visit after they have been been screened, consented and enrolled during visit 1.
Intervention Type
Other
Intervention Name(s)
Low FODMAP Diet
Intervention Description
Both arms will receive the intervention but at different time points.
Primary Outcome Measure Information:
Title
Adequate symptom relief between cases and controls
Description
Adequate symptom relief assessed by questionnaire after intervention in cases and before intervention in cases
Time Frame
Assessed in cases on their last day of the intervention (2 weeks after dietary change). Assessed in controls before they began their intervention (between 1-2 weeks before dietary changes)
Secondary Outcome Measure Information:
Title
Changes in colonic volume between cases and controls from baseline
Description
A change in colonic volume measured in milliliters (ml) from baseline and after intervention in cases. This will compared with a change in colonic volume from baseline and before intervention in controls.
Time Frame
Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)
Title
Changes in fermentation between cases and controls
Description
A change in breath hydrogen concentration measured in parts per million (ppm) from: baseline and after intervention (cases) ii) from baseline and before intervention (controls)
Time Frame
Measured : i) baseline (day 0), ii) last day of intervention (cases) (2 weeks after dietary change), iii) before intervention (2 weeks before dietary advice)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 and above Able to give informed consent Previous Diagnosis of IBS by medical practitioner Meeting ROME III criteria for IBS Investigations showing negative tissue transglutaminase (tTG) IgA antibodies Full blood count test does not indicate Anaemia Exclusion Criteria: Inclusion Aged 18 and above Able to give informed consent Previous Diagnosis of IBS by medical practitioner Meeting ROME III criteria for IBS Investigations showing negative tissue transglutaminase (tTG) IgA antibodies Full blood count test does not indicate Anaemia Exclusion Children (<18 years) 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 Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder Intestinal stoma Limited understanding of English Pregnancy declared by the candidate Red flag symptoms such as rectal bleeding, family history of bowel or ovarian cancer, a change in bowel habit to looser and/or more frequent stools persisting for more than six weeks in a person aged over 60 years. Investigations showing positive tissue transglutaminase (tTG) IgA antibodies Anaemia confirmed by full blood count test 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. chaotic lifestyle related to substance abuse 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 Participants taking prebiotic/probiotic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Spiller, MD,FRCP
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham Digestive Diseases Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

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