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fMRI and Visceral Perception Upon Capsaicin Infusion

NCT02551029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Capsaicin

OTHER

Placebo

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • A.A.M. Masclee, Prof. MD. PhD · Maastricht University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-07-26
Completion
2019-07-26

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551029 on ClinicalTrials.gov