ClinicalTrials.gov
ClinicalTrials.gov Menu

fMRI and Visceral Perception Upon Capsaicin Infusion

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: NCT02551029
Recruitment Status : Unknown
Verified March 2016 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 16, 2015
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
Brain imaging has shown abnormal brain activations in response to visceral stimulation in patients with the Irritable Bowel Syndrome (IBS). 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 evaluating the possible role of NTS activation in visceral abdominal pain. Moreover, this will be the first fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is more physiological than mechano-stimulation.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Colonic Diseases, Functional Dyspepsia Gastrointestinal Diseases Abdominal Pain Visceral Pain Other: Capsaicin Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain and Brainstem Activation Following Duodenal Nociceptive Stimulation With Capsaicin, an Exploratory High-resolution fMRI Study in Healthy Volunteers
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Duodenal capsaicin infusion
Through a naso-duodenal tube, a capsaicin solution will be infused into the duodenum. After infusion with capsaicin for several minutes, placebo (saline) infusion into the duodenum follows. Thereafter, capsaicin infusion will recommence, followed again by placebo infusion
Other: Capsaicin
Other Name: Capsaicin oleoresina solution infusion into the duodenum.

Other: Placebo
Other Name: Saline infusion into the duodenum




Primary Outcome Measures :
  1. Activation of the Nucleus of the Solitary Tract [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo

  2. Activation of the Nucleus of the Solitary Tract [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the functional ASL (arterial spin labelling) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo


Secondary Outcome Measures :
  1. Activity and connectivity in the Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary Somatosensory Cortex, Amygdala, PAG [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the functional ASL and BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo

  2. Questionnaire for pain (Visual Analogue Scores) [ Time Frame: During capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    Scores range from 0 [no pain] to 10 [worst possible pain].

  3. Questionnaire for depression and anxiety [ Time Frame: During the test day, before scanning ]
    Hospital Anxiety and Depression Scale (HADS)

  4. Questionnaire for depression [ Time Frame: During the test day (= day 1), before scanning ]
    PHQ-9 scores

  5. Questionnaire for personality trait [ Time Frame: During the test day (= day 1), before scanning ]
    BIG FIVE Inventory

  6. Questionnaire for quality of life [ Time Frame: During the test day (= day 1), before scanning ]
    SF-36 (quality of life) scores

  7. Questionnaire for current affent scores [ Time Frame: During the test day (= day 1), before scanning ]
    PANAS-SF (current affect) scores

  8. Questionnaire for current pain [ Time Frame: During the test day (= day 1), before scanning ]
    Brief Pain Inventory (BPI) scores

  9. Microbiota [ Time Frame: Subjects will provide a fecal sample on the test day (= day 1) ]
    different bacteria in stool

  10. Questionnaire for anxiety [ Time Frame: During the test day (= day 1), before scanning ]
    GAD-7 scores

  11. Questionnaire for the assessment of Gastrointestinal symptom scores [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the GSRS and the GSRS-IBS

  12. Questionnaire for the assessment of early life traumata [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the ETISR-SF



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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 (<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.

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): NCT02551029


Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 ER
Contact: Z. Weerts, MD       z.weerts@maastrichtuniversity.nl   
Principal Investigator: A.A.M. Masclee, Prof. MD. PhD         
Principal Investigator: D. Keszthelyi, MD. PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: A.A.M. Masclee, Prof. MD. PhD Maastricht University

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02551029     History of Changes
Other Study ID Numbers: METC 152048
NL51770.068.15 ( Other Identifier: CCMO )
METC 152048 ( Other Identifier: METC Azm/UM )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

Keywords provided by Maastricht University Medical Center:
Magnetic Resonance Imaging
Brainstem
Solitary Nucleus
Visceral Nervous System
Transient Receptor Potential Channels

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Dyspepsia
Abdominal Pain
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Visceral Pain
Colonic Diseases, Functional
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Nociceptive Pain
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs