An interventional study of gastric capsaicin with heterotopic stimulation/ distraction in Functional Dyspepsia, sponsored by National University Hospital, Singapore. Completed at 2 sites in Singapore. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-07.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Diagnostic
Visceral hypersensitivity as evidence of central sensory sensitization is evident in many patients with functional disorders such as functional dyspepsia (FD) and irritable bowel syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes. Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal modulation could explain several of the symptom complexes associated with FD and provide a rationale for exploration of new treatments.
The current study was designed to
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 80 is close to the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
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FD patients:
Healthy controls:
Exclusion Criteria:
Exclusion criteria for both FD patients and healthy controls:
Eighty male and female FD patients according to Rome III criteria (Drossman, 2006), aged 18 to 70 years, will be recruited from primary and secondary care via advertisements and our referral networks
Procedure: gastric capsaicin with heterotopic stimulation/ distraction
Forty male and female healthy volunteers, aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months will be recruited.
Procedure: gastric capsaicin with heterotopic stimulation/ distraction
The subjects are randomized to swallow either a capsaicin 0.50mg capsule or an identical placebo capsule with 100ml of water If after 15 minutes pain scores do not reach a minimum level of 30, a further double-blinded capsule of the same content will be swallowed with 100ml of water. This is repeated to a maximum of 8 capusles until pain with VAS \>30 is reported.
Differences between healthy controls and FD subjects in visceral pain scores.
Time frame: within 2 hours of Capsaicin challenge
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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National University Hospital, Singapore