Asymptomatic Conditions
Conditions
Keywords
small bowel, bloating, flow
Brief summary
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.
Detailed description
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.
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 or older * Able to give informed consent
Exclusion criteria
* 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 * Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products * Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury * Will not agree to dietary restrictions required in 24 hours before each study day * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Small Bowel Water Content Measured by MRI | 0-3 hours | Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL\*min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ascending Colon Water Content | 0-3 hours | Area under the curve of postprandial change from fasting ascending colon water, 0-3 hours, measured by MRI, in mL\*min |
| Relaxation Time in Ascending Colon | 0-3 hours | Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI in milliseconds.min |
| Bloating VAS Score | 0-180 min | 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. |
| Satiety VAS Score | 0-180 mins | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
15 included in final analysis as scanner failure caused loss of data for 3 subjects
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers Healthy volunteer group who participated | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | scanner failure | 0 | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Healthy Volunteers | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 15 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
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
Time frame: 0-3 hours
Population: 15 healthy volunteers free from GI disorders.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers. Bread Arm. | Small Bowel Water Content Measured by MRI | -5662 mL*min | Standard Error 1209 |
| Healthy Volunteers. Lettuce Arm | Small Bowel Water Content Measured by MRI | 3194 mL*min | Standard Error 1574 |
| Healthy Volunteers. Rhubarb Arm | Small Bowel Water Content Measured by MRI | 10586 mL*min | Standard Error 1629 |
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
Time frame: 0-3 hours
Population: Healthy Volunteers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers. Bread Arm. | Ascending Colon Water Content | 78 mL*min | Standard Error 43 |
| Healthy Volunteers. Lettuce Arm | Ascending Colon Water Content | 409 mL*min | Standard Error 231 |
| Healthy Volunteers. Rhubarb Arm | Ascending Colon Water Content | 291 mL*min | Standard Error 89 |
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.
Time frame: 0-180 min
Population: Healthy volunteers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers. Bread Arm. | Bloating VAS Score | 4196 VAS Score*Min | Standard Error 637 |
| Healthy Volunteers. Lettuce Arm | Bloating VAS Score | 7071 VAS Score*Min | Standard Error 905 |
| Healthy Volunteers. Rhubarb Arm | Bloating VAS Score | 5113 VAS Score*Min | Standard Error 927 |
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
Time frame: 0-3 hours
Population: Healthy volunteers free from GI disorders
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers. Bread Arm. | Relaxation Time in Ascending Colon | 15188 ms*min | Standard Error 6717 |
| Healthy Volunteers. Lettuce Arm | Relaxation Time in Ascending Colon | 18990 ms*min | Standard Error 7884 |
| Healthy Volunteers. Rhubarb Arm | Relaxation Time in Ascending Colon | 35744 ms*min | Standard Error 9013 |
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.
Time frame: 0-180 mins
Population: Healthy volunteers free from GI disorders
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers. Bread Arm. | Satiety VAS Score | 7943 VAS Score*Mins | Standard Error 783 |
| Healthy Volunteers. Lettuce Arm | Satiety VAS Score | 9498 VAS Score*Mins | Standard Error 941 |
| Healthy Volunteers. Rhubarb Arm | Satiety VAS Score | 7904 VAS Score*Mins | Standard Error 835 |