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| Name | Class |
|---|---|
| Quadram Institute Bioscience | OTHER |
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The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
4. BACKGROUND AND RATIONALE
The challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Previous studies 1 have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigation will exploiting a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances 2.
The mode of action of methylcellulose and psyllium on the reduction in gas production from inulin remains unclear. Possible mechanisms include 1) slowing delivery to the colon by their effect in the small bowel, 2) delayed release of inulin from the dietary fibre gel matrix (i.e. a physical effect) in the colon 3) or a direct effect on the colonic bacteria reducing their production of gas (i.e. a microbiological effect).
References
Aim This pilot study will test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.
Objective The primary objective of this pilot is to compare the effect of pre-feeding a gel-forming dietary fibre (methylcellulose or psyllium) compared to placebo (water) on the colonic fermentability of Inulin over the six hours immediately post inulin ingestion as assessed from breath hydrogen production.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psyllium | Active Comparator | 15g psyllium + 15 inulin dissolved in 250 ml water |
|
| Methylcelulose | Active Comparator | 15g methylcellulose +15 g inulin dissolved in 250 ml water |
|
| Maltodextrin | Placebo Comparator | 15g maltodextrin +15 g inulin dissolved in 250 ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inulin | Other | inulin from chicory root |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breath hydrogen AUC | Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake. | 0-6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Breath hydrogen AUC | Area under curve (AUC) from time 0-24hours (AUC 0-24) of breath hydrogen (ppm.hour) after consumption of inulin intake. | 0-24h |
| Whole gut transit | Time for blue colour to appear after ingesting muffin labelled with blue food colouring |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin Spiller, MD | Contact | 07824328319 | robin.spiller@nottingham.ac.uk | |
| Joshuah Reid, PhD | Contact | 07540418235 | sbzjer@exmail.nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Robin C Spiller, MD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Digestive Disease Centre | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34353864 | Result | Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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randomised placebo controlled crossover study
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gels given in opaque plastic bag
| 0-7days |
| D004066 | Digestive System Diseases |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |