Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel (LETIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02939716
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Robin Spiller, University of Nottingham

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.


Condition or disease Intervention/treatment Phase
Asymptomatic Conditions Other: Rhubarb Other: Bread Other: Lettuce Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Assess the Effect of Lettuce on Intestinal Water Content Through Magnetic Resonance Imaging of the Small Bowel: LETIS
Study Start Date : October 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rhubarb
300g frozen rhubarb, microwaved; served with 65g lactose free cream and saccharine sweetener
Other: Rhubarb
300gm rhubarb

Active Comparator: Bread
2 slices of white bread, 40g each; served with 10g butter
Other: Bread
2 slices bread

Experimental: Lettuce
300g lettuce; served with 30g mayonnaise
Other: Lettuce
300g lettuce




Primary Outcome Measures :
  1. Small bowel water content measured by MRI, in mL [ 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


Secondary Outcome Measures :
  1. Ascending colon water content [ Time Frame: 0-3 hours ]
    Area under the curve of postprandial change from fasting ascending colon water, 0-3 hours, measured by MRI, in mL

  2. Relaxation time in ascending colon [ Time Frame: 0-3 hours ]
    Area under the curve of postprandial change from fasting small bowel water, 0-3 hours, measured by MRI in milliseconds

  3. Bloating [ Time Frame: 0-3 hours ]
    Area under the curve of postprandial change from fasting bloating score, 0-3 hours, measured by 100 point visual analogue scale

  4. Satiety [ Time Frame: 0-3 hours ]
    Area under the curve of postprandial change from fasting satiety score, 0-3 hours, measured by 100 point visual analogue scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939716


Locations
Layout table for location information
United Kingdom
Sir Peter Mansfield Imaging Centre
Nottingham, United Kingdom, NG7 2RD
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham

Layout table for additonal information
Responsible Party: Robin Spiller, Professor of Gastroenterology, University of Nottingham
ClinicalTrials.gov Identifier: NCT02939716     History of Changes
Other Study ID Numbers: C12072016 MRI
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robin Spiller, University of Nottingham:
small bowel
bloating
flow

Additional relevant MeSH terms:
Layout table for MeSH terms
Asymptomatic Diseases
Disease Attributes
Pathologic Processes