Functional Dyspepsia
Conditions
Brief summary
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 1. investigate the gastric sensitivity in FD patients and healthy controls during gastric capsaicin stimulation 2. assess the endogenous pain inhibitory modulation system in FD patients and healthy controls during heterotopic stimulation
Interventions
PROCEDUREgastric 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.
Sponsors
NMRC, Singapore
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
FD patients: * 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. * FD discomfort or pain should be the most prominent symptom. * Patients must have been off all FD and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start and be able to remain off such medication for the duration of the study period. Healthy controls: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences between healthy controls and FD subjects in visceral pain scores. | within 2 hours of Capsaicin challenge |
Countries
Singapore
Outcome results
None listed