AzTrials
AzTrials

Irritable Bowel SyndromeNCT02551029

fMRI and Visceral Perception Upon Capsaicin Infusion

A study testing Capsaicin in people with Irritable Bowel Syndrome and Colonic Diseases, Functional, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
Capsaicin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
1 siteNetherlands
Study dates
Feb 2016to 26 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Medical Center

    Maastricht, 6229 ER

Other trials in Netherlands

About this study

Official title: Brain and Brainstem Activation Following Duodenal Nociceptive Stimulation With Capsaicin, an Exploratory High-resolution fMRI Study in Healthy Volunteers

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.

Being tested
Capsaicin, Placebo
Keywords
Magnetic Resonance Imaging, Brainstem, Solitary Nucleus, Visceral Nervous System, Transient Receptor Potential Channels
Medical subject headings
Irritable Bowel Syndrome, Colonic Diseases, Functional, Dyspepsia, Gastrointestinal Diseases, Abdominal Pain, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapsaicinOther

    Also called Capsaicin oleoresina solution infusion into the duodenum.

  • PlaceboOther

    Also called Saline infusion into the duodenum

Study groups in NCT02551029
Study groupRoleWhat they receive
Duodenal capsaicin infusionExperimentalThrough a naso-duodenal tube, a capsaicin solution will be infused into the duodenum.
Receives: Other: Capsaicin
Placebo (saline)Placebo comparatorThrough a naso-duodenal tube, a saline solution will be infused into the duodenum.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activation of the Nucleus of the Solitary Tract

    the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo

    Measured: During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes

Secondary outcomes (13)

  1. Activity and connectivity in the Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary Somatosensory Cortex, Amygdala, PAG

    the functional BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo

    Measured: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes

  2. Questionnaire for pain (Visual Analogue Scores)

    Scores range from 0 [no pain] to 10 [worst possible pain].

    Measured: During capsaicin and placebo infusion between t=0 and and t=38 minutes

  3. Questionnaire for depression and anxiety

    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.

    Measured: During the test day, before scanning

  4. Questionnaire for depression

    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.

    Measured: During the test day (= day 1), before scanning

  5. Questionnaire for personality trait

    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.

    Measured: During the test day (= day 1), before scanning

  6. Questionnaire for quality of life

    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.

    Measured: During the test day (= day 1), before scanning

  7. Questionnaire for current affect scores

    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.

    Measured: During the test day (= day 1), before scanning

  8. Questionnaire for current pain

    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.

    Measured: During the test day (= day 1), before scanning

  9. Questionnaire for anxiety

    GAD-7 scores, for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 has seven items, 0-3 scale.

    Measured: During the test day (= day 1), before scanning

  10. Questionnaire for the assessment of Gastrointestinal symptom scores

    Scores of the GSRS, scale 1-7, generates subscores for abdominal pain, reflux, diarrhea, constipation, indigestion

    Measured: During the test day (= day 1), before scanning

  11. Questionnaire for the assessment of Gastrointestinal symptom scores

    Scores of the GSRS-IBS, scale 1-7, generates subscores for abdominal pain, bloating, constipation, diarrhea, satiety.

    Measured: During the test day (= day 1), before scanning

  12. Questionnaire for the assessment of early life traumata

    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).

    Measured: During the test day (= day 1), before scanning

  13. Questionnaire for the assessment of gastrointestinal specific anxiety

    Scores of the Visceral Sensitivity Index, a 15 item questionnaire, scale 1-6, assesses gastrointestinal (GI)-specific anxiety.

    Measured: During the test day (= day 1), before scanning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion26 Jul 2019
  4. Study completion26 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551029
Sponsor's protocol ID
METC 152048
Other IDs
NL51770.068.15, METC 152048
Status last verified
Jun 2020
First submitted
25 Aug 2015
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Beckers AB, van Oudenhove L, Weerts ZZRM, Jacobs HIL, Priovoulos N, Poser BA, Ivanov D, Gholamrezaei A, Aziz Q, Elsenbruch S, Masclee AAM, Keszthelyi D. Evidence for engagement of the nucleus of the solitary tract in processing intestinal chemonociceptive input irrespective of conscious pain response in healthy humans. Pain. 2022 Aug 1;163(8):1520-1529. doi: 10.1097/j.pain.0000000000002538. Epub 2021 Nov 15.

    PubMed 34799534

Questions about this trial

What is this clinical trial studying?

A study testing Capsaicin in people with Irritable Bowel Syndrome and Colonic Diseases, Functional, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activation of the Nucleus of the Solitary Tract (time frame: During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02551029, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in