Completed

NCT Number: NCT01963364

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

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.

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Key information

Conditions

Evidence of Adaptation to Dietary Exposure to Fructans

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham Digestive Diseases Centre, Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inulin challenge

Dietary Supplement

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)

oligofructose supplement

Dietary Supplement

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)

Primary outcomes

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.

Secondary outcomes

Change in fasting colonic volume

Time frame: Baseline and after one week of intervention

Calculated from segmentation on MRI scans
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
Change in fasting colonic gas volume, measured in millilitres

Time frame: Baseline and after one week of intervention

Measured using MRI segmentation technique
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
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
Change in faecal 5-HIAA concentration in μmol/g

Time frame: baseline and after one week of intervention

measured by high performance liquid chromatography

Other outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: PERFECT

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Oct 16, 2013
Registry last updated: Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.