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When patients have bowel surgery they are sometimes left with a stoma, where the small bowel exits onto the wall of the abdomen, not into the colon. Certain foods have been shown to increase the amount of water lost through a stoma. This can lead to dehydration. Such patients are encouraged to avoid such foods but knowing which ones to avoid relies partly on trial and error.
In a survey 1 in 3 patients said that rhubarb increased stoma output. Rhubarb is known to contain chemicals that can stimulate the bowel. 1 in 6 patients also reported the same effect with lettuce which has not previously been shown to have such an effect. Latex found in lettuce leaves may stimulate the bowel to produce more fluid, explaining this effect.
In Nottingham the investigators have developed techniques that use Magnetic Resonance Imaging (MRI) to measure water in the small bowel. They want to use these techniques to explore whether eating lettuce increase small bowel water content. They will compare lettuce to rhubarb and to bread, which they know reduces small bowel water. They will see if they can detect any relationship between water in the bowel and feelings of bloating.
Background:
In recent years fermentable oligo-, di-, mono-saccharides and polyols, have been proposed to exacerbate symptoms of irritable bowel syndrome (IBS) such as abdominal discomfort and bloating. This phenomenon has also been observed in patients with an ileostomy, where certain foods have been associated with increased fluid output from the stoma. This is in accordance with past work surveying ileostomy patients on foods that altered stoma function. However, there may be other factors that drive fluid output from a stoma. Rhubarb, a food listed by 1 in 3 patients as exacerbating watery diarrhoea, also contains anthraquinones that have laxative effects, such as in senna.
A food less commonly associated with laxative effects is lettuce but 1 in 6 patients reported that eating lettuce led to an increase in watery stoma output. Certain lettuce varieties exude a milk-like latex material when cut, giving rise to the latin name Lactuca sativa. While the methylcellulose is insoluble and would not be expected to hold water in the lumen of the small bowel, latex could be expected to stimulate intestinal secretion. This may contribute to post-prandial sensations of bloating by a different mechanism to the osmotic effects and colonic fermentation seen with poorly absorbed but fermentable carbohydrates..
The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly digested carbohydrates on gastrointestinal physiology. the investigators have published techniques to measure free water in the small bowel and assessment of viscosity in the colon using MR relaxometry. This includes the demonstration that fructose ingestion on its own leads to increased free water in the small bowel compared to co-ingestion with glucose - see panel. The investigators wish to apply these techniques to compare the effect of different foods: white bread, lettuce and rhubarb. The investigators have previously shown that bread led to a reduction in small bowel water and so can active as a negative control. Rhubarb should serve as a positive control.
Aims: The purpose of the study is gather pilot data on the effect of different foods on intestinal physiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhubarb | Active Comparator | 300g frozen rhubarb, microwaved; served with 65g lactose free cream and saccharine sweetener |
|
| Bread | Active Comparator | 2 slices of white bread, 40g each; served with 10g butter |
|
| Lettuce | Experimental | 300g lettuce; served with 30g mayonnaise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhubarb | Other | 300gm rhubarb |
| |
| Bread |
| Measure | Description | Time Frame |
|---|---|---|
| Small Bowel Water Content Measured by MRI | Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL*min | 0-3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ascending Colon Water Content | Area under the curve of postprandial change from fasting ascending colon water, 0-3 hours, measured by MRI, in mL*min | 0-3 hours |
| Relaxation Time in Ascending Colon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Spiller | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Peter Mansfield Imaging Centre | Nottingham | NG7 2RD | United Kingdom | |||
| Nottingham Digestive Diseases Centre |
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15 included in final analysis as scanner failure caused loss of data for 3 subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers. Bread Then Lettuce Then Rhubarb | Healthy volunteers free from GI disease. Randomised to order Bread then Lettuce then Rhubarb |
| FG001 | Healthy Volunteers. Bread Then Rhubarb Then Lettuce | Healthy volunteers free from GI disease. Randomised to order Bread then Rhubarb then Lettuce |
| FG002 | Healthy Volunteers. Lettuce Then Rhubarb Then Bread | Healthy volunteers free from GI disease. Randomised to order Lettuce then Rhubarb then Bread |
| FG003 | Healthy Volunteers. Lettuce Then Bread Then Rhubarb | Healthy volunteers free from GI disease. Randomised to order Lettuce then Bread then Rhubarb |
| FG004 | Healthy Volunteers. Rhubarb Then Bread Then Lettuce | Healthy volunteers free from GI disease. Randomised to order Rhubarb then Bread then Lettuce |
| FG005 | Healthy Volunteers. Rhubarb Then Lettuce Then Bread | Healthy volunteers free from GI disease. Randomised to order Rhubarb then Lettuce then Bread |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Healthy volunteer group who participated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Small Bowel Water Content Measured by MRI | Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL*min | 15 healthy volunteers free from GI disorders. | Posted | Mean | Standard Error | mL*min | 0-3 hours |
|
From initial participant recruitment visit to last participant visit. This covered 4 months from Sept 2016- January 2017. There was no follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers. Bread Then Lettuce Then Rhubarb | Healthy Volunteers. Treatment order Bread Then Lettuce Then Rhubarb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Spiller | University of Nottingham | 01158231090 | robin.spiller@nottingham.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2016 | Oct 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058070 | Asymptomatic Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000630126 | rhubarb peony decoction |
| D001939 | Bread |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Other |
2 slices bread |
|
| Lettuce | Other | 300g lettuce |
|
Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI in milliseconds.min
| 0-3 hours |
| Bloating VAS Score | Area under the curve of postprandial change from fasting bloating score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins. | 0-180 min |
| Satiety VAS Score | Area under the curve of postprandial change from fasting satiety score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins. | 0-180 mins |
| Nottingham |
| NG7 2UH |
| United Kingdom |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Rhubarb Arm
|
|
| Secondary | Ascending Colon Water Content | Area under the curve of postprandial change from fasting ascending colon water, 0-3 hours, measured by MRI, in mL*min | Healthy Volunteers | Posted | Mean | Standard Error | mL*min | 0-3 hours |
|
|
|
| Secondary | Relaxation Time in Ascending Colon | Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI in milliseconds.min | Healthy volunteers free from GI disorders | Posted | Mean | Standard Error | ms*min | 0-3 hours |
|
|
|
| Secondary | Bloating VAS Score | Area under the curve of postprandial change from fasting bloating score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins. | Healthy volunteers | Posted | Mean | Standard Error | VAS Score*Min | 0-180 min |
|
|
|
| Secondary | Satiety VAS Score | Area under the curve of postprandial change from fasting satiety score, 0-180 min, measured by a 100 point visual analogue scale (VAS), where 0 is no symptom and 100 is worst symptom. Measured every 30 mins. | Healthy volunteers free from GI disorders | Posted | Mean | Standard Error | VAS Score*Mins | 0-180 mins |
|
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Healthy Volunteers. Bread Then Rhubarb Then Lettuce | Healthy Volunteers. Treatment order Bread Then Rhubarb Then Lettuce | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Healthy Volunteers. Lettuce Then Rhubarb Then Bread | Healthy Volunteers. Treatment order Lettuce Then Rhubarb Then Bread | 0 | 3 | 0 | 3 | 0 | 3 |
| EG003 | Healthy Volunteers. Lettuce Then Bread Then Rhubarb | Healthy Volunteers. Treatment order Lettuce Then Bread Then Rhubarb | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Healthy Volunteers. Rhubarb Then Bread Then Lettuce | Healthy Volunteers. Treatment order Rhubarb Then Bread Then Lettuce | 0 | 3 | 0 | 3 | 0 | 3 |
| EG005 | Healthy Volunteers. Rhubarb Then Lettuce Then Bread | Healthy Volunteers. Treatment order Rhubarb Then Lettuce Then Bread | 0 | 3 | 0 | 3 | 0 | 3 |
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