Irritable Bowel Syndrome (IBS)
Conditions
Interventions
Duodenal capsaicin and placebo (saline + small amount of ethanol) infusion via
a nasoduodenal tube.
Capsaicin
Functional Gastrointestinal Disorders
Functional Magnetic Resonance
Irritable Bowel Syndrome
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Of female sex; * Based on medical history and previous examination, no gastrointestinal complaints can be defined; * Age between 18 and 65 years; * BMI between 18 and 30 kg/m2; * Women in fertile age (
Exclusion criteria
Exclusion criteria: * Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, facial tattoos (including permanent eye make-up) and/or other metal objects; * History of major head trauma or head/brain surgery; * History of claustrophobia; * History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol; * Use of medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study; * Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgment of the principle investigator); * Pregnancy, lactation, wish to become pregnant; * High alcohol consumption (>15 alcoholic consumptions per week); * Using drugs of abuse; * Self-admitted HIV-positive state; * Known allergic reaction to capsaicin; * High intake of spicy (capsaicin containing) food (meaning an estimated intake of > than 1.5mg/day), due to possible desensitization of the capsaicin receptor TRPV1 (see further below); * Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study; * Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (ASL-) Voxel-wise blood oxygenation level dependent (BOLD) signal activity in the NTS. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Voxel-wise blood oxygenation level dependent BOLD signal activity in the Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary Somatosensory Cortex, Amygdala, PAG * Baseline Cerebral Blood Flow * Visual Analogue Scores during capsaicin and placebo infusion into the duodenum * Gastro-intestinal Symptom Scores, Depression and Anxiety symptom scores (HADS, PHQ-9, GAD-7), personality trait (BIG-FIVE-Inventory), Traumata in early life, quality of life scores (SF-36), current affect scores (PANAS-SF), current pain scores (BPI-SF) and gastrointestinal symptom scores (GSRS-IBS+), visceral sensitivity index (VSI) | — |
Countries
The Netherlands
Outcome results
None listed