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fMRI and Visceral Perception Upon Capsaicin Infusion

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ClinicalTrials.gov Identifier: NCT02551029
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
KU Leuven
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) 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.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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.
Other: Capsaicin
Other Name: Capsaicin oleoresina solution infusion into the duodenum.

Placebo Comparator: Placebo (saline)
Through a naso-duodenal tube, a saline solution will be infused 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=38 minutes ]
    the BOLD (Voxel-wise blood oxygenation level dependent) 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 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=38 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). Has 14 items (7 for depression, 7 for anxiety) with a 4 points likert scale (0-3). Scores for depression and anxiety range from 0-21 and studies identified 8 as the cutoff-point.

  4. Questionnaire for depression [ Time Frame: During the test day (= day 1), before scanning ]
    PHQ-9 scores (patient health questionnaire). The questionnaire has 9 items with a 4 points likert scale (0-3) and a total score of 27. A total score of 0-4 indicates none to minimal depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

  5. Questionnaire for personality trait [ Time Frame: During the test day (= day 1), before scanning ]
    BIG FIVE Inventory, the Big Five Inventory (BFI) survey that measures the big five dimensions of personality (extraversion, neuroticism, consciousness, agreeableness, and openness to experience). The questionnaire has 44 items.

  6. Questionnaire for quality of life [ Time Frame: During the test day (= day 1), before scanning ]
    SF-36 (quality of life) scores, The Short Form (36) Health Survey questionnaire of 36 items, scale 1-6, generates a physical and a mental QoL component summary.

  7. Questionnaire for current affent scores [ Time Frame: During the test day (= day 1), before scanning ]
    PANAS-SF (current affect) scores, Positive and Negative Affect Schedule. This is a 20 item questionnaire (scale 1-5) total scores can range from 10 - 50, with higher scores representing higher levels of positive affect.

  8. Questionnaire for current pain [ Time Frame: During the test day (= day 1), before scanning ]
    Brief Pain Inventory (BPI) scores, The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub- items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.

  9. Questionnaire for anxiety [ Time Frame: During the test day (= day 1), before scanning ]
    GAD-7 scores, for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 has seven items, 0-3 scale.

  10. Questionnaire for the assessment of Gastrointestinal symptom scores [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the GSRS, scale 1-7, generates subscores for abdominal pain, reflux, diarrhea, constipation, indigestion

  11. Questionnaire for the assessment of Gastrointestinal symptom scores [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the GSRS-IBS, scale 1-7, generates subscores for abdominal pain, bloating, constipation, diarrhea, satiety.

  12. Questionnaire for the assessment of early life traumata [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the ETISR-SF, The Early Trauma Inventory Self Report - Short Form comprises of 27 items, divided into four dimensions (general trauma, physical abuse, emotional abuse and sexual abuse) and scored on a dichotomous scale (Yes/No).

  13. Questionnaire for the assessment of gastrointestinal specific anxiety [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the Visceral Sensitivity Index, a 15 item questionnaire, scale 1-6, assesses gastrointestinal (GI)-specific anxiety.



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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    0433885798      
Principal Investigator: A.A.M. Masclee, Prof. MD. PhD         
Principal Investigator: D. Keszthelyi, MD. PhD         
Sub-Investigator: A.B. Beckers, MD.         
Sub-Investigator: L. Oudenhoven, MD. PhD         
Sub-Investigator: D. Ivanov, PhD         
Sub-Investigator: H.I.L. Jacobs, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
KU Leuven
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: November 30, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Dyspepsia
Irritable Bowel Syndrome
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
Pharmaceutical Solutions
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs