Irritable Bowel Syndrome Clinical Trial
Official title:
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
In this study, the investigators aim to assess the effect of acute FODMAP infusion on
gastric motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers
and 20 patients with irritable bowel syndrome (IBS) will undergo respectively four and
two/three pressure measurements of the stomach after an overnight fast as a measure for
gastric motility. During this pressure measurement, which takes approximately 4 hours, one
of four FODMAP or control solutions will be administered directly into the stomach through a
nasogastric tube. Administration will be stopped when the participant is fully satiated. The
four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a
fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS
patients, only the fructan and glucose solution will be tested, where after they can choose
to come for a third visit to test the fructose solution. The solutions will be tested on
separate occasions in a randomized order.
During the pressure measurement, participants will be asked to complete several
questionnaires: (1) a gastrointestinal symptom questionnaire to assess their
gastrointestinal symptoms, (2) a satiation questionnaire during infusion of one of the
solutions, (3) psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible
psychological effects of FODMAP infusion.
The investigators hypothesize that there will be differences in gastric motility between
healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal
symptoms will be increased in IBS patients, and that FODMAP infusion will have more
psychological effects in patients than in healthy volunteers.
In this study, the investigators aim to assess the effect of acute FODMAP infusion on
gastric motility and on gastrointestinal and psychological symptoms. This is a randomised,
single-blinded, crossover study of different solutions, differing in FODMAP content. The
four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a
fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS
patients, only the fructan and glucose solution will be tested, where after they can choose
to come for a third visit to test the fructose solution. The different solutions will be
tested on separate occasions, three days to one week apart, in a randomised order.
The preparation of each study visit will be identical. After an overnight fast, participants
will be asked to come to the clinic. To ensure a low baseline symptom level and low
microbial gut activity, a diet low in fibre and fermentable carbohydrates will be followed
the day prior to each test (information will be provided to assist this). Participants will
be asked to refrain from alcohol, tea and coffee, and intense physical activity for at least
12 hours before participation. They will also be asked to refrain from smoking cigarettes at
least one hour before the start of the experiment.
A high resolution manometry probe will be inserted through the nose into the stomach of the
participant to assess intragastric pressure as a measure of gastric motility and gastric
accommodation. In addition, an infusion tube will be positioned in the proximal stomach to
administer the solution. The position of the probes will be checked fluoroscopically
(maximum 15 seconds). In this case, relevant guidelines of radioprotection will be adhered
to. Patients will be protected by a lead shield that covers the lower abdomen and all
personnel will wear a lead jacket. After the catheters are fixed to the subjects' chin, the
patients will be asked to sit at a table and remain in this position for the remainder of
the experiment.
After a stabilization period of at least 15 minutes, and when the subject is in phase II of
the hunger cycle, one of four solutions will be intragastrically administered at a constant
speed of 60 mL per minute (determined by an automated system using a peristaltic pump). IGP
will be recorded for the duration of the drink infusion and for the following 3 hours.
During infusion, the subjects will be asked to score their satiation at 1-minute intervals
using a graphic rating scale that combines verbal descriptors on a scale graded of 0-5 (1,
threshold; 5, maximum satiety). The intragastric infusion will be stopped as soon as a score
of 5 is reached on their satiation scores. In addition, participants will be asked to
complete a gastrointestinal symptom questionnaire every 15 minutes. The participant's
emotions and mood will be assessed before, immediately after and 1, 2 and 3 hours after
infusion, using the State-Trait Anxiety Inventory (STAI) and the validated Dutch version of
the Positive and Negative Affect Scale (PANAS). Emotional state will be repeatedly measured
every 15 minutes using the Self-Assessment Manikin (SAM) and Profile of Mood States
(POMS)-Fatigue subscale.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
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