Irritable Bowel SyndromeFOGNCT02259465
The Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota
A study testing low FODMAP diet, Oligofructose and Maltodextrin in people with Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- low FODMAP diet, Oligofructose and Maltodextrin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Able to give informed consent
Who cannot join
- Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
Show all 16Show fewer
- 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
- Will not limit alcohol intake to ≤ 35 units/ week and ≤ 8 units per day during trial
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Antibiotic or prescribed probiotic treatment in the past 8 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Diseases Centre
Nottingham, NG7 2UH
About this study
Official title: A Randomised Controlled Trial of the Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota in Healthy Volunteers
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 immune reaction to the carbohydrate from the bowel wall.
Read the detailed description
Oligofructose (OF) is a fructose- based oligosaccharide and defined in the European Union as a dietary fibre. Enzymatically derived from the longer chain inulin in chicory, it is commonly used in processed food to improve mouth feel in fat-free products. OF is poorly digested and absorbed in the small bowel so passes to the colon where it is fermented by the bacteria usually resident in the colon, termed the microbiota. This process produces gases such as hydrogen and sometimes methane, and short-chain fatty acids (SCFAs) which have a variety of roles including nutrition to colonocytes, immunological effects and modulation of intestinal motility. Its presence in the colon alters the composition of the microbiota, with reported potential benefits to health, leading to its description as a 'prebiotic'.
Recently, however, such poorly digested carbohydrates grouped together by the term FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) have been proposed to exacerbate symptoms of irritable bowel syndrome (IBS) such as abdominal discomfort and bloating. Dietary exclusion of foods containing FODMAPs, such as wheat, dairy and certain fruit and vegetables, has been proposed as a treatment for IBS, with some evidence to support this. FODMAPs are thought to induce symptoms either by drawing water into the small bowel by osmosis, or through gaseous distension of the large bowel or a combination of these along with metabolite effects on motility.
The Nottingham GI MRI group has been at the forefront of elucidating the actual effects of FODMAPs on gastrointestinal (GI) physiology. We have published techniques to measure small bowel water content, colonic volume and gas volume and whole gut transit time. We have recently demonstrated that a single, large (40g) dose of inulin leads to an increase in colonic volume, mainly through an increase in colonic gas. Such a dose is beyond the usual range of dietary variation, however. Last year we piloted a model more similar to dietary practice. Participants supplemented their usual diet with 5g OF twice daily for a week. The most striking result was an 18% increase in fasting colonic volume. This could not be explained by changes in colonic gas and may represent proliferation, and increased mass, of the microbiota. That study was an open label, uncontrolled case series so we now wish to test the hypothesis in a double-blind, randomised controlled trial. For explanatory purposes we will also measure whole gut transit, colonic gas volume and hydrogen and methane expired in the breath. For exploratory purposes we will also collect stool and urine samples to allow assessment of the effect on microbiota and their metabolic output.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- low FODMAP diet, Oligofructose, Maltodextrin
- Keywords
- microbiota, FODMAP, oligofructose, Magnetic Resonance Imaging, Metabolomics, Diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAP dietBehavioural
Participants will attend a one-hour group session on how to follow the low FODMAP diet, run by a dietitian trained in the diet. They will be asked to follow the diet for 7 days while keeping a food diary.
OligofructoseDietary supplement
Also called OraftiP95, OF
Participants will supplement their diet with 7 grams of OF twice daily for the week that they follow the low FODMAP diet.
MaltodextrinDietary supplement
Participants will supplement their diet with 7 grams of maltodextrin twice daily for the week that they follow the low FODMAP diet.
| Study group | Role | What they receive |
|---|---|---|
| Oligofructose | Active comparator | Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with oligofructose, 7grams twice daily Receives: Behavioral: low FODMAP diet; Dietary Supplement: Oligofructose |
| Maltodextrin | Placebo comparator | Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with maltodextrin, 7grams twice daily Receives: Behavioral: low FODMAP diet; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colonic volume
Percentage change from baseline in fasting colonic volume after one week of intervention, as measured by Magnetic Resonance Imaging (MRI)
Measured: one week
Secondary outcomes (4)
Change in whole gut transit time
Change in whole gut transit time (WGTT) after one week of intervention, as determined by Weighted Average Position Score (WAPS) of MRI transit markers 24 hours after ingestion
Measured: one week
Change in colonic gas volume
Percentage change in fasting colonic gas volume after one week of intervention, as measured by MRI
Measured: one week
Change in fasting breath hydrogen
Change in fasting breath hydrogen concentration after one week of intervention, measured in parts per million
Measured: one week
Change in fasting breath methane
Change in fasting breath methane concentration after one week of intervention, measured in parts per million
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MD FRCP, Study chair, University of NottinghamGiles AD Major, BMBCh MRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259465
- Sponsor's protocol ID
- SoM A14082014 FOG
- Acronym
- FOG
- Status last verified
- Mar 2015
- First submitted
- 3 Oct 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02259465
- Acronym / sponsor ID
- FOG / SoM A14082014 FOG
- Conditions
- Irritable Bowel Syndrome
- Keywords
- microbiota, FODMAP, oligofructose, Magnetic Resonance Imaging, Metabolomics, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 immune reaction to the carbohydrate from the bowel wall.
Detailed description
Oligofructose (OF) is a fructose- based oligosaccharide and defined in the European Union as a dietary fibre. Enzymatically derived from the longer chain inulin in chicory, it is commonly used in processed food to improve mouth feel in fat-free products. OF is poorly digested and absorbed in the small bowel so passes to the colon where it is fermented by the bacteria usually resident in the colon, termed the microbiota. This process produces gases such as hydrogen and sometimes methane, and short-chain fatty acids (SCFAs) which have a variety of roles including nutrition to colonocytes, immunological effects and modulation of intestinal motility. Its presence in the colon alters the composition of the microbiota, with reported potential benefits to health, leading to its description as a 'prebiotic'.
Recently, however, such poorly digested carbohydrates grouped together by the term FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) have been proposed to exacerbate symptoms of irritable bowel syndrome (IBS) such as abdominal discomfort and bloating. Dietary exclusion of foods containing FODMAPs, such as wheat, dairy and certain fruit and vegetables, has been proposed as a treatment for IBS, with some evidence to support this. FODMAPs are thought to induce symptoms either by drawing water into the small bowel by osmosis, or through gaseous distension of the large bowel or a combination of these along with metabolite effects on motility.
The Nottingham GI MRI group has been at the forefront of elucidating the actual effects of FODMAPs on gastrointestinal (GI) physiology. We have published techniques to measure small bowel water content, colonic volume and gas volume and whole gut transit time. We have recently demonstrated that a single, large (40g) dose of inulin leads to an increase in colonic volume, mainly through an increase in colonic gas. Such a dose is beyond the usual range of dietary variation, however. Last year we piloted a model more similar to dietary practice. Participants supplemented their usual diet with 5g OF twice daily for a week. The most striking result was an 18% increase in fasting colonic volume. This could not be explained by changes in colonic gas and may represent proliferation, and increased mass, of the microbiota. That study was an open label, uncontrolled case series so we now wish to test the hypothesis in a double-blind, randomised controlled trial. For explanatory purposes we will also measure whole gut transit, colonic gas volume and hydrogen and methane expired in the breath. For exploratory purposes we will also collect stool and urine samples to allow assessment of the effect on microbiota and their metabolic output.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligofructose | Active comparator | Behavioral: low FODMAP diet, Dietary Supplement: OligofructoseParticipants will be asked to follow the low FODMAP diet for a week, supplementing the diet with oligofructose, 7grams twice daily |
| Maltodextrin | Placebo comparator | Behavioral: low FODMAP diet, Dietary Supplement: MaltodextrinParticipants will be asked to follow the low FODMAP diet for a week, supplementing the diet with maltodextrin, 7grams twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 or older
- Able to give informed consent
Key exclusion criteria (16 listed)
- Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low FODMAP dietParticipants will attend a one-hour group session on how to follow the low FODMAP diet, run by a dietitian trained in the diet. They will be asked to follow the diet for 7 days while keeping a food diary. | Behavioural | Maltodextrin, Oligofructose |
| OligofructoseAlso: OraftiP95, OFParticipants will supplement their diet with 7 grams of OF twice daily for the week that they follow the low FODMAP diet. | Dietary supplement | Oligofructose |
| MaltodextrinParticipants will supplement their diet with 7 grams of maltodextrin twice daily for the week that they follow the low FODMAP diet. | Dietary supplement | Maltodextrin |
Primary outcome
Change in colonic volume
Time frame: one week
Percentage change from baseline in fasting colonic volume after one week of intervention, as measured by Magnetic Resonance Imaging (MRI)
4 secondary outcomes
Change in whole gut transit time
Time frame: one week
Change in colonic gas volume
Time frame: one week
Change in fasting breath hydrogen
Time frame: one week
Change in fasting breath methane
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin C Spiller, MD FRCP study chair
University of Nottingham
Giles AD Major, BMBCh MRCP principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low FODMAP diet, Oligofructose and Maltodextrin in people with Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in colonic volume (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.