G62.88
Conditions
Interventions
Group 1: Patients with idiopathic small fiber neuropathy
1. study visit (2-3h): patient history incl. PainDETECT pain questionnaire, Beck's Depression Inventory, Montgomery Asberg Depression Scale, D
Sponsors
Klinik für Neurologie Universitätsklinikum RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed small fiber neuropathy 2. No underlying acquired origin of nerve damage 3. Male or female aged = 18 years 4. Written informed consent prior to project participation 5. The subject is willing and able to follow the procedures outlined in the project plan
Exclusion criteria
Exclusion criteria: 1. Acquired cause of neuropathy (Diabetes mellitus, alcohol consumption, kidney insufficiency, vitamin deficiency) 2. Clinical criteria for the diagnosis of small fiber neuropathy not fulfilled 3. Patient has been committed to an institution by legal or regulatory order 4. Participation in a parallel interventional clinical trial 5. The subject is mentally or legally incapacitated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify gastrointestinal transit times in patients diagnosed with small fiber neuropathy. Patients eat a specifically prepared muffin containing a non-toxic, non-absorbable blue dye that will be tracked for one month. For that, we will use an app as a patient diary (poop app), which will help to document the presence of blue colour in their stools. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To correlate GI transit times with subjective symptoms (patient history) • To correlate GI transit times with neuropathic pain and medication history (anamnesis, PainDETECT pain questionnaire) • To investigate drug bioavailability and biomarker profiles from breath air in correlation with GI transit times (breath gas analysis via Proton-Transfer-Reaction Mass Spectrometry, blood levels pain medication) | — |
Countries
Germany
Contacts
Public ContactGreta Peschke
Klinik für Neurologie Universitätsklinikum RWTH Aachen
Outcome results
None listed