Trial record 1 of 2 for:    Open Studies | "Flatulence"
Previous Study | Return to List | Next Study

Fructose and Fructans in IBS (FABS)

This study is currently recruiting participants.
Verified February 2014 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01776853
First received: January 23, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to investigate if patients with Irritable Bowel Syndrome (IBS) who also report bloating are more likely to report clinically important gastrointestinal symptoms after consuming fructose or fructans than after consuming glucose. We will also use MRI imaging to investigate the mechanisms by which those symptoms might be caused.

We will also study a parallel group of age and gender frequency matched healthy volunteers to provide descriptive statistics on a likely reference range for the healthy population.

Irritable Bowel Syndrome (IBS) is a common chronic condition, the main features of which are pain in the abdomen, an erratic bowel habit and sometimes bloating. Recent research has found that certain carbohydrates (sugars) in the diet can cause symptoms such as discomfort, bloating and wind/gas in people with IBS. These sugars are not well digested in the small bowel. They move to the colon (large bowel) where bacteria act on them by fermentation, producing gas. Some of the gas is absorbed and breathed out through the lungs, where we can measure it. The rest is released as flatulence/ wind, or occasionally belching. People without IBS rarely get symptoms after consuming these sugars. We want to find out what is different in IBS sufferers.

We will study fructose and fructans, sugars found in fruit, vegetables and wheat. Fructose draws water into the small bowel but fructans do not so we can compare effects on the small bowel and colon. Participants will attend three times, and on each occasion consume a drink containing either fructose, fructans, or glucose - a sugar that does not cause symptoms. Neither they nor the investigators present will know which drink is which. They will record their symptoms over the next 5 hours. We will observe how many report a clinically important increase in symptoms.

To look at what is happening in the bowel we will use a technique called Magnetic Resonance Imaging (MRI). We want to see if more gas, or water, builds up in people with IBS than in healthy volunteers. We will also measure the amount of hydrogen released in the breath to see if this is could be a simple bedside test that agrees with the MRI findings

Finding differences between the response of participants to fructose, fructans and glucose could change the way we advise patients, and could lead to the use of MRI as a test for IBS.


Condition Intervention
Irritable Bowel Syndrome
Dietary Supplement: Glucose
Dietary Supplement: Fructose
Dietary Supplement: Fructans

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Fructose and Fructans and Irritable Bowel Syndrome: MRI Study of Underlying Mechanisms

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Symptom response (yes/no) [ Time Frame: At any point 0-5 hours after exposure ] [ Designated as safety issue: No ]

    Clinically important GI symptoms (yes/no) reported by participants in the 5 hours after exposure.

    • We will measure 4 symptoms from a previously validated questionnaire (Suarez 1995) on a scale of 0 (none), 1 (mild/ distinct but negligible), 2 (moderate/ annoying), 3 (severe/ disabling)
    • Symptoms include abdominal pain, bloating, gas/flatulence, and diarrhoea.
    • We will add together scores for each symptom to get the total score (min 0; max 12)
    • We will define clinically important symptoms as additive total score of 3 or greater.


Secondary Outcome Measures:
  • Symptom Intensity [ Time Frame: 0-5 hours after intervention ] [ Designated as safety issue: No ]

    Intensity of symptoms measured by Visual Analogue Scale (Shepherd 2008)

    • Symptoms include abdominal pain, bloating, gas/ flatulence and diarrhoea.
    • We will add together scores for each symptom to get the total score (min 0; max 400). Measurements will be taken at hourly time points from before intervention to 5 hours post-intervention, and an area under the curve (AUC) will be calculated. Measurements will also be taken at intermediate timepoints to better identify the onset of symptoms.

  • Breath Hydrogen [ Time Frame: 0-5 hours after intervention ] [ Designated as safety issue: No ]
    Excretion of H2 (hydrogen) gas in breath, measured in parts per million (ppm). Measurements will be taken at hourly time points from before intervention to 5 hours post-intervention, and an area under the curve (AUC) will be calculated. Measurements will also be taken at intermediate timepoints to better identify the start of the rise in breath hydrogen.

  • Colonic Gas Volume [ Time Frame: 0-5 hours after intervention ] [ Designated as safety issue: No ]
    Volume of gas in the colon as measured on MRI, in millilitres (ml). Measurements will be taken at hourly time points from before intervention to 5 hours post-intervention, and an area under the curve (AUC) will be calculated.

  • Small Bowel Water Content [ Time Frame: 0-5 hours after intervention ] [ Designated as safety issue: No ]
    Volume of free water in the small bowel, as measured by MRI imaging in millilitres (ml). Measurements will be taken at hourly time points from before intervention to 5 hours post-intervention, and an area under the curve (AUC) will be calculated.


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Glucose
40g glucose in 500ml water flavoured with lime juice
Dietary Supplement: Glucose
Experimental: Fructose
40g fructose in 500ml water flavoured with lime juice
Dietary Supplement: Fructose
Experimental: Fructans
40g fructans in 500ml water flavoured with lime juice
Dietary Supplement: Fructans

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who meet the Rome III research diagnostic criteria for IBS(Longstreth 2006) who also report bloating OR
  • Healthy volunteers who do not meet Rome III clinical diagnostic criteria for IBS
  • Aged 18-65
  • Able to give informed consent

Exclusion Criteria:

  • Any reported history of gastrointestinal surgery (excluding appendicectomy or cholecystectomy)
  • Presence of an intestinal stoma
  • Pregnancy declared by candidate
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Reported alcohol dependence
  • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
  • Antibiotic or probiotic treatment in the past 4 weeks
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • Poor understanding of English language
  • Participation of any medical trials for the past 3 months
  • Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe Chronic Obstructive Pulmonary Disease(COPD)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776853

Contacts
Contact: Giles AD Major, BM BCh MA MRCP +44 (115) 9515151 ext 31073 giles.major@nottingham.ac.uk

Locations
United Kingdom
NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Giles AD Major, BM BCh MA MRCP    +44 (0115) 9515151 ext 31073    giles.major@nottingham.ac.uk   
Principal Investigator: Giles AD Major, BM BCh MA MRCP         
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Robin C Spiller, MB BChir MSc MD FRCP NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham
Principal Investigator: Giles AD Major, BM BCh MA MRCP NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham
Study Director: Mark R Fox, BM BCh MA MD FRCP NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham
  More Information

Additional Information:
Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01776853     History of Changes
Other Study ID Numbers: 12102, 12/EM/0443
Study First Received: January 23, 2013
Last Updated: February 25, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by University of Nottingham:
Irritable Bowel Syndrome
Fructose
Fructans
MRI
Fermentation
Breath Tests
Flatulence
Abdominal Pain
Diarrhoea

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Levan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014