fMRI and Visceral Perception Upon Capsaicin Infusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-07-26

Brief Summary

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Brain imaging has shown abnormal brain activations in response to visceral stimulation in patients with the Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD). To investigate the possible role of the Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior to this, an exploratory study in healthy volunteers will be conducted. This will be the first high magnetic field fMRI study (7T) evaluating the possible role of NTS activation in visceral abdominal pain. Moreover, this will be the first pharmacological fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is more physiological than mechano-stimulation in the upper gastrointestinal tract.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Colonic Diseases, Functional Dyspepsia Gastrointestinal Diseases Abdominal Pain Visceral Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Duodenal capsaicin infusion

Through a naso-duodenal tube, a capsaicin solution will be infused into the duodenum.

Group Type EXPERIMENTAL

Capsaicin

Intervention Type OTHER

Placebo (saline)

Through a naso-duodenal tube, a saline solution will be infused into the duodenum.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Capsaicin

Intervention Type OTHER

Placebo

Intervention Type OTHER

Other Intervention Names

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Capsaicin oleoresina solution infusion into the duodenum. Saline infusion into the duodenum

Eligibility Criteria

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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 (\<55 years old) must use contraception or be postmenopausal for at least two years.
* All subjects should be right-handed.

Exclusion Criteria

* Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes