NCT02939716: LETIS

A Pilot Study to Assess the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel: LETIS

Completed NA Results posted Last updated 20 July 2020

What this trial tests

NA trial testing Rhubarb in Asymptomatic Conditions in 18 participants. Completed in 1 February 2017.

Timeline

1 October 2016

Primary endpoint
1 February 2017

1 February 2017

Quick facts

Lead sponsor	University of Nottingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	18
Start date	1 October 2016
Primary completion	1 February 2017
Estimated completion	1 February 2017
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Rhubarb — full drug profile →
• Bread
• Lettuce

Conditions studied

• Asymptomatic Conditions — all drugs for Asymptomatic Conditions →

Sponsor

University of Nottingham

Who can join

18 and older, any sex, with Asymptomatic Conditions. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Small Bowel Water Content Measured by MRI
  Time frame: 0-3 hours
  Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI, in mL\*min

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.