N/A
N=18
Assessing the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel
Asymptomatic Conditions
Bottom Line
View on ClinicalTrials.gov: NCT02939716 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Small Bowel Water Content Measured by MRI — -5662; 3194; 10586 mL*min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rhubarb (Other); Bread (Other); Lettuce (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nottingham
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Small Bowel Water Content Measured by MRI |
-5662; 3194; 10586 | — |
| SECONDARY Ascending Colon Water Content |
78; 409; 291 | — |
| SECONDARY Relaxation Time in Ascending Colon |
15188; 18990; 35744 | — |
| SECONDARY Bloating VAS Score |
4196; 7071; 5113 | — |
| SECONDARY Satiety VAS Score |
7943; 9498; 7904 | — |
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.
Eligibility Criteria
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 exclusion criteria)
- 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 in the morning
- 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
Data sourced from ClinicalTrials.gov (NCT02939716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.