HealthyFODMAPsNCT01459406
Effects of FODMAPs on Small Bowel Water Content: an MRI Study
A study testing Glucose, Fructose and Fructan in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients suffering from the irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glucose, Fructose and Fructan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Dec 2012
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy: no medical conditions which might effect study measurements.
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- Age ≥ 18 and ≤ 60 year at pre-study investigation.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
- No reported participation in night shift work two days prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
- Strenuous exercise ≤ 10 hours per week.
Show all 10Show fewer
- Gender: male or female
- Consumption of ≤ 21 alcoholic drinks in a typical week
- Currently not smoking
- Suitable for MRI scanning (e.g., absence of metal implants, infusion pumps and pacemakers) as assessed by the attached MRI safety questionnaire.
Who cannot join
- - use of medication which interferes with study measurements or bowel motility (as judged by the study physician).
- Antibiotics in the 3 weeks before pre-study examination
- Probiotics or during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, Nottinghamshire, NG72UH
About this study
Official title: Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on Small Bowel Water Content: an MRI Study
Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients suffering from the irritable bowel syndrome (IBS). This may be because they are not well absorbed in the small intestine and cause water to be trapped in the bowel causing distension. Studies have shown that reducing the amount of these sugars in the diet can relieve these symptoms. There is some evidence that combining fructose and glucose can reduce the symptoms caused by fructose but just why is unclear. In this study, the investigators will use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the behaviour of drinks containing these sugars in the bowels of healthy human volunteers.
The investigators will give four different drinks: one beverage consisting of a very well absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a third which is a mixture of glucose and fructose, and a fourth consisting of several fructose subunits joined together (called fructan). The investigators will take MRI images of the stomach and intestines at intervals for 5 hours and compare these with the feelings of distension and bloating in our volunteers. The results will act as control for subsequent studies in IBS patients and these may help design diets to reduce symptoms in IBS.
Read the detailed description
Title: Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on small bowel water content: an MRI study
- Background. FODMAPs consist of fructose, lactose, fructo- and galacto-oligosaccharides such as fructans and galactans, and polyols such as sorbitol and mannitol. These carbohydrates are poorly absorbed in the small intestine and have been shown to trigger symptoms of irritable bowel syndrome (IBS). Previous studies have shown that fructose malabsorption results in an increased osmotic load in the small bowel, which can have a laxative effect. Physical proof of this has only been obtained using an ileostomy model on patients. This study indicated increased small bowel water content (SBWC) but this has never been established in intact humans .). We have been using noninvasive magnetic resonance imaging (MRI) to provide novel insights on the fate of food materials within the gastro-intestinal tract (GIT) of humans for the last decade.
- Aims (to include hypothesis to be tested) This study aims to investigate whether fructose alone will increase SBWC compared to an equivalent mass of glucose, and if adding glucose to fructose will reduce its effect on the SBWC. The study also aims to determine if fructans alter colonic transit.The main hypothesis is that fructose will increase small bowel water while fructans will mainly affect colonic transit..
- Experimental protocol and methods. A single-centre, randomized, cross-over design study consisting of a screening visit and four test days, which will be approximately 1 week apart The subjects (18 healthy volunteers for main study plus 4 for pilot studies) will receive (according to a randomization schedule) each test day one out of four test products: 1) glucose (control) 2) fructose, 3) glucose with fructose and 4) fructans. On each test day, volunteers will have a baseline scan in a 1.5T scanner, consume one of the products instead of breakfast at 09:00 and will be imaged in the scanner at intervals for 5 hours using a range of MRI sequences.
All the tested ingredients are food grade, have a history of safe use at intended usage levels, and are regarded as safe.
Four test products will be evaluated:
- 500 mL of glucose (40g of glucose dissolved in water with pure lime juice as flavorant)
- 500 mL fructose (40g fructose dissolved in water with pure lime juice as flavorant)
- 500 mL of glucose with fructose (40g glucose and 40g fructose dissolved in water with pure lime juice as flavorant, 40 or 80 gm)
- 500 mL fructan (40g of 100% fructan (inulin) dissolved in water with pure lime juice as flavorant)
- Measurable end points/statistical power of the study. Primary endpoint: small bowel water content area under the curve (AUC) -45 - 315 minutes. Secondary endpoint: gastric emptying T50, colonic volume as characterised by AUC -45 - 315 minutes of ascending colon, colonic motility, symptoms questionnaires, small bowel transit time, breath hydrogen concentrations and tryptase faecal content.
Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40 minutes postprandial after ingesting 300ml glucose was 47 (SD 15) and using n=12 the investigators calculate the investigators can detect an increase of 20 ml in excess of this with 90% power which is very much less than the investigators are predicting. The investigators plan to use 18 to ensure the investigators can assess our secondary endpoints for which there is no data with which to perform a power calculation.
- Conditions
- Healthy
- Being tested
- Glucose, Fructose, Fructan, Fructose and glucose
- Keywords
- Gastrointestinal physiology, Gastrointestinal response to sugars, MRI, gastrointestinal, stomach, small bowel, colon, glucose, fructose, fructan, FODMAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseDietary supplement
500 ml water drink containing 40g glucose
FructoseDietary supplement
500 ml water drink containing 40g fructose
FructanDietary supplement
500 ml water drink containing 40g fructan
Fructose and glucoseDietary supplement
500 ml water drink containing 40g fructose and 40g glucose
| Study group | Role | What they receive |
|---|---|---|
| Glucose drink | Experimental | Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g glucose Receives: Dietary Supplement: Glucose |
| Fructose drink | Experimental | Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose Receives: Dietary Supplement: Fructose |
| Fructan drink | Experimental | Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructan Receives: Dietary Supplement: Fructan |
| Fructose and glucose drink | Experimental | Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose and 40 g glucose Receives: Dietary Supplement: Fructose and glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
small bowel water content area under the curve
Area Under the curve for small bowel water content, methods as Marciani, L., et al., Gastroenterology, 2010. 138(2): p. 469-U90. Hoad, C.L., et al.,. Physics in Medicine and Biology, 2007. 52(23): p. 6909-6922.
Measured: -45 min to 315 min
Secondary outcomes (6)
gastric emptying T50
time to half empty the stomach
Measured: -45 min to 315 min
ascending colon volume
AUC of the geometric volume of the ascending colon
Measured: -45 min to 315 min
ascending colon motility
motility index of the ascending colon as determined from dynamic MRI scan
Measured: -45 min to 315 min
symptoms questionnaires
bloating, nausea, gas belching and abdominal pain
Measured: -45 min to 315 min
bowel transit time
first time to detect sweetcorn markers in the stool
Measured: 24 hours
fecal tryptase activity
activity of stool triptase in trypsin units of activity
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MD FRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459406
- Sponsor's protocol ID
- L/7/2011
- Acronym
- FODMAPs
- Status last verified
- Dec 2012
- First submitted
- 21 Oct 2011
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
PubMed 20659225Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.
PubMed 19909743Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
PubMed 18029983Gibson PR, Barrett JS. The concept of small intestinal bacterial overgrowth in relation to functional gastrointestinal disorders. Nutrition. 2010 Nov-Dec;26(11-12):1038-43. doi: 10.1016/j.nut.2010.01.005. Epub 2010 Apr 24.
PubMed 20418060Shepherd SJ, Parker FC, Muir JG, Gibson PR. Dietary triggers of abdominal symptoms in patients with irritable bowel syndrome: randomized placebo-controlled evidence. Clin Gastroenterol Hepatol. 2008 Jul;6(7):765-71. doi: 10.1016/j.cgh.2008.02.058. Epub 2008 May 5.
PubMed 18456565Shepherd SJ, Gibson PR. Fructose malabsorption and symptoms of irritable bowel syndrome: guidelines for effective dietary management. J Am Diet Assoc. 2006 Oct;106(10):1631-9. doi: 10.1016/j.jada.2006.07.010.
PubMed 17000196Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.
PubMed 20102355Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.
PubMed 17990113Rumessen JJ, Gudmand-Hoyer E. Fructans of chicory: intestinal transport and fermentation of different chain lengths and relation to fructose and sorbitol malabsorption. Am J Clin Nutr. 1998 Aug;68(2):357-64. doi: 10.1093/ajcn/68.2.357.
PubMed 9701194Bond JH Jr, Levitt MD, Prentiss R. Investigation of small bowel transit time in man utilizing pulmonary hydrogen (H2) measurements. J Lab Clin Med. 1975 Apr;85(4):546-55.
PubMed 1120927
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on Small Bowel Water Content: an MRI Study
- ClinicalTrials.gov ID
- NCT01459406
- Acronym / sponsor ID
- FODMAPs / L/7/2011
- Conditions
- Healthy
- Keywords
- Gastrointestinal physiology, Gastrointestinal response to sugars, MRI, gastrointestinal, stomach, small bowel, colon, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Oct 2011 (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, particularly fructose, the sugar found in fruit and bread may cause bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients suffering from the irritable bowel syndrome (IBS). This may be because they are not well absorbed in the small intestine and cause water to be trapped in the bowel causing distension. Studies have shown that reducing the amount of these sugars in the diet can relieve these symptoms. There is some evidence that combining fructose and glucose can reduce the symptoms caused by fructose but just why is unclear. In this study, the investigators will use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the behaviour of drinks containing these sugars in the bowels of healthy human volunteers.
The investigators will give four different drinks: one beverage consisting of a very well absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a third which is a mixture of glucose and fructose, and a fourth consisting of several fructose subunits joined together (called fructan). The investigators will take MRI images of the stomach and intestines at intervals for 5 hours and compare these with the feelings of distension and bloating in our volunteers. The results will act as control for subsequent studies in IBS patients and these may help design diets to reduce symptoms in IBS.
Detailed description
Title: Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on small bowel water content: an MRI study
- Background. FODMAPs consist of fructose, lactose, fructo- and galacto-oligosaccharides such as fructans and galactans, and polyols such as sorbitol and mannitol. These carbohydrates are poorly absorbed in the small intestine and have been shown to trigger symptoms of irritable bowel syndrome (IBS). Previous studies have shown that fructose malabsorption results in an increased osmotic load in the small bowel, which can have a laxative effect. Physical proof of this has only been obtained using an ileostomy model on patients. This study indicated increased small bowel water content (SBWC) but this has never been established in intact humans .). We have been using noninvasive magnetic resonance imaging (MRI) to provide novel insights on the fate of food materials within the gastro-intestinal tract (GIT) of humans for the last decade.
- Aims (to include hypothesis to be tested) This study aims to investigate whether fructose alone will increase SBWC compared to an equivalent mass of glucose, and if adding glucose to fructose will reduce its effect on the SBWC. The study also aims to determine if fructans alter colonic transit.The main hypothesis is that fructose will increase small bowel water while fructans will mainly affect colonic transit..
- Experimental protocol and methods. A single-centre, randomized, cross-over design study consisting of a screening visit and four test days, which will be approximately 1 week apart The subjects (18 healthy volunteers for main study plus 4 for pilot studies) will receive (according to a randomization schedule) each test day one out of four test products: 1) glucose (control) 2) fructose, 3) glucose with fructose and 4) fructans. On each test day, volunteers will have a baseline scan in a 1.5T scanner, consume one of the products instead of breakfast at 09:00 and will be imaged in the scanner at intervals for 5 hours using a range of MRI sequences.
All the tested ingredients are food grade, have a history of safe use at intended usage levels, and are regarded as safe.
Four test products will be evaluated:
- 500 mL of glucose (40g of glucose dissolved in water with pure lime juice as flavorant)
- 500 mL fructose (40g fructose dissolved in water with pure lime juice as flavorant)
- 500 mL of glucose with fructose (40g glucose and 40g fructose dissolved in water with pure lime juice as flavorant, 40 or 80 gm)
- 500 mL fructan (40g of 100% fructan (inulin) dissolved in water with pure lime juice as flavorant)
- Measurable end points/statistical power of the study. Primary endpoint: small bowel water content area under the curve (AUC) -45 - 315 minutes. Secondary endpoint: gastric emptying T50, colonic volume as characterised by AUC -45 - 315 minutes of ascending colon, colonic motility, symptoms questionnaires, small bowel transit time, breath hydrogen concentrations and tryptase faecal content.
Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40 minutes postprandial after ingesting 300ml glucose was 47 (SD 15) and using n=12 the investigators calculate the investigators can detect an increase of 20 ml in excess of this with 90% power which is very much less than the investigators are predicting. The investigators plan to use 18 to ensure the investigators can assess our secondary endpoints for which there is no data with which to perform a power calculation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose drink | Experimental | Dietary Supplement: GlucoseSerial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g glucose |
| Fructose drink | Experimental | Dietary Supplement: FructoseSerial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose |
| Fructan drink | Experimental | Dietary Supplement: FructanSerial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructan |
| Fructose and glucose drink | Experimental | Dietary Supplement: Fructose and glucoseSerial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose and 40 g glucose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Apparently healthy: no medical conditions which might effect study measurements.
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- Age ≥ 18 and ≤ 60 year at pre-study investigation.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
- No reported participation in night shift work two days prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
Key exclusion criteria (3 listed)
- - use of medication which interferes with study measurements or bowel motility (as judged by the study physician).
- Antibiotics in the 3 weeks before pre-study examination
- Probiotics or during the study
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 |
|---|---|---|
| Glucose500 ml water drink containing 40g glucose | Dietary supplement | Glucose drink |
| Fructose500 ml water drink containing 40g fructose | Dietary supplement | Fructose drink |
| Fructan500 ml water drink containing 40g fructan | Dietary supplement | Fructan drink |
| Fructose and glucose500 ml water drink containing 40g fructose and 40g glucose | Dietary supplement | Fructose and glucose drink |
Primary outcome
small bowel water content area under the curve
Time frame: -45 min to 315 min
Area Under the curve for small bowel water content, methods as Marciani, L., et al., Gastroenterology, 2010. 138(2): p. 469-U90. Hoad, C.L., et al.,. Physics in Medicine and Biology, 2007. 52(23): p. 6909-6922.
6 secondary outcomes
gastric emptying T50
Time frame: -45 min to 315 min
ascending colon volume
Time frame: -45 min to 315 min
ascending colon motility
Time frame: -45 min to 315 min
symptoms questionnaires
Time frame: -45 min to 315 min
bowel transit time
Time frame: 24 hours
fecal tryptase activity
Time frame: 24 h
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 19 Dec 2012.
- Background: PubMed 20659225Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.
- Background: PubMed 19909743Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.
- Background: PubMed 18029983Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
- Background: PubMed 20418060Gibson PR, Barrett JS. The concept of small intestinal bacterial overgrowth in relation to functional gastrointestinal disorders. Nutrition. 2010 Nov-Dec;26(11-12):1038-43. doi: 10.1016/j.nut.2010.01.005. Epub 2010 Apr 24.
- Background: PubMed 18456565Shepherd SJ, Parker FC, Muir JG, Gibson PR. Dietary triggers of abdominal symptoms in patients with irritable bowel syndrome: randomized placebo-controlled evidence. Clin Gastroenterol Hepatol. 2008 Jul;6(7):765-71. doi: 10.1016/j.cgh.2008.02.058. Epub 2008 May 5.
- Background: PubMed 17000196Shepherd SJ, Gibson PR. Fructose malabsorption and symptoms of irritable bowel syndrome: guidelines for effective dietary management. J Am Diet Assoc. 2006 Oct;106(10):1631-9. doi: 10.1016/j.jada.2006.07.010.
- Background: PubMed 20102355Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.
- Background: PubMed 17990113Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.
- Background: PubMed 9701194Rumessen JJ, Gudmand-Hoyer E. Fructans of chicory: intestinal transport and fermentation of different chain lengths and relation to fructose and sorbitol malabsorption. Am J Clin Nutr. 1998 Aug;68(2):357-64. doi: 10.1093/ajcn/68.2.357.
- Background: PubMed 1120927Bond JH Jr, Levitt MD, Prentiss R. Investigation of small bowel transit time in man utilizing pulmonary hydrogen (H2) measurements. J Lab Clin Med. 1975 Apr;85(4):546-55.
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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 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 Glucose, Fructose and Fructan in people with Healthy, 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 10 inclusion and 3 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 19 Dec 2012. 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. 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?
small bowel water content area under the curve (time frame: -45 min to 315 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459406, which also lists 10 linked publications.
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 19 Dec 2012.