The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
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.
Healthy volunteers:

 Inclusion Criteria:

 -  Aged between 18 to 65 years old

 Exclusion Criteria:

 -  Current symptoms or history of gastrointestinal disease, other significant diseases,
 psychological disorders, drug allergies or pregnancy

 -  Taking any medication or have any drug history

 IBS patients:

 Inclusion Criteria:

 -  Meet Rome III criteria for IBS. This is defined as recurrent abdominal pain or
 discomfort at least 3 days/month in the last 3 months associated with two or more of
 the following: improvement with defecation; onset associated with a change in
 frequency of stool; or onset associated with a change in form (appearance) of stool

 -  Aged between 18 to 65 years old

 Exclusion criteria:

 -  Other significant diseases, psychological disorder, drug allergies or pregnancy

 -  Taking any non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids or other
 immunosuppressive drugs in the preceding 6 months. All drugs potentially affecting
 gastrointestinal motility or sensitivity will be discontinued at least 1 week before
 the gastric emptying study.