Pilot Study of the Effect of Fructans on Fermentation in the Colon & Transit (PERFECT)

January 16, 2014 updated by: University of Nottingham

A Pilot Study Using Magnetic Resonance Imaging to Measure the Effect of Dietary Supplementation With Fructans on Whole Gut Transit Time, Colonic Gas Volume, and Volume Change in Response to a Fructan Challenge

Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot be digested by humans. When eaten they pass through the small bowel to the large bowel, or colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use them as an energy source. This releases energy that humans can absorb, and may have other effects on health as well. The process also releases gases such as hydrogen and methane into the colon, which will eventually be released as flatulence.

There is some evidence in animals, and humans, that changing the carbohydrate content of the diet may increase the numbers of bacteria in the colon that can use this energy source. Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect transit, the speed at which food and stool moves through the stomach and bowels. This undergraduate project will use techniques in Magnetic Resonance Imaging developed in Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed of transit through the bowel and gas production in the colon, and whether there is any evidence of a change in the level of signalling chemicals that may affect bowel function.

Study Overview

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nottingham, United Kingdom, Ng7 2UH
        • Nottingham Digestive Diseases Centre
      • Nottingham, United Kingdom, NG7 2RD
        • Sir Peter Mansfield Magnetic Resonance Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18-55
  • Able to give informed consent
  • Does not meet criteria for diagnosis of IBS on Rome III questionnaire

Exclusion Criteria:

  • Unable to abstain from smoking for the duration of the study (may affect breath hydrogen readings)
  • Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye
  • Pregnancy declared by candidate
  • Female patients during their menstrual period
  • 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
  • Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
  • 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 in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
  • Strenuous exercise greater than 10 hours per week (i.e. no competition training the week prior to the study).
  • Participation in any medical trials for the past 3 months
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
All healthy volunteers
On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin.
Other Names:
  • Orafti HP (Beneo-Orafti, Belgium)
Starting at the end of study day 1, consumption of 5 grams oligofructose coloured with carmine red food dye(<5%), dissolved in a hot drink, twice daily for 6 1/2 days/ 13 doses. The 14th dose of the week is the inulin challenge consumed as part of study day 1.
Other Names:
  • Orafti P95 (Beneo-Orafti P95, Belgium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in whole gut transit time after one week (measured in hours) calculated using MRI marker capsule technique
Time Frame: Difference (Delta) between baseline and after one week of intervention
5 markers pills will be swallowed 24 hours before MRI scanning. Each pill will be given a score 0-9 based on the colonic segment where it is located. The weighted mean of these scores will be the geometric centre. Previous validation allows a transit time to be calculated from the geometric centre.
Difference (Delta) between baseline and after one week of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting colonic volume
Time Frame: Baseline and after one week of intervention
Calculated from segmentation on MRI scans
Baseline and after one week of intervention
Change in colonic volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres
Time Frame: Baseline and after one week of intervention
Calculated from segmentation on MRI scans
Baseline and after one week of intervention
Change in fasting colonic gas volume, measured in millilitres
Time Frame: Baseline and after one week of intervention
Measured using MRI segmentation technique
Baseline and after one week of intervention
Change in colonic gas volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres
Time Frame: Baseline and after one week of intervention
Calculated from segmentation on MRI scans
Baseline and after one week of intervention
Change in breath hydrogen concentration, measured in parts per million before, 4 hours after, and 8 hours after ingestion of 40 grams inulin
Time Frame: Baseline and after one week of intervention
Baseline and after one week of intervention
Change in faecal 5-HIAA concentration in μmol/g
Time Frame: baseline and after one week of intervention
measured by high performance liquid chromatography
baseline and after one week of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of clinically important digestive symptoms during study day or intervention week
Time Frame: one week of intervention
  • We will measure 4 symptoms from a previously validated questionnaire on a scale of 0 (none), 1 (mild/ distinct but negligible), 2 (moderate/ annoying), 3 (severe/ disabling), and also on a Visual Analogue Scale (0-100)
  • Symptoms include abdominal pain, bloating, gas/flatulence, and diarrhoea.
  • We will define clinically important symptoms as a composite score of 3 or more at any time point or on any day.
one week of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Giles Major, MD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (ESTIMATE)

October 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 11072013SCSMRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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