An interventional study of Skin biopsy in Small Fiber Neuropathy and Gastrointestinal Dysmotility, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.
47 studies on the registry are indexed under Small Fiber Neuropathy; 12 are open to participants now.
Browse Small Fiber Neuropathy studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Procedure: Skin biopsy
Procedure: Skin biopsy
Any combination of the following six 3-6mm skin biopsies may be taken: palm, dorsum of hand, calf, other non-genital and non-face (this last one includes areas for use as negative controls which are not on the distal limbs). No more than 6 biopsies will be taken at one time.The biopsy size 3-6mm and method (punch, shave or wedge) will be done depending on the biologic assay destined for the biopsy. While 3mm will be sufficient for microarray analysis, 6mm will be required for any cell sorting preceding microarray analysis.
Presence of small fiber neuropathy in skin biopsy samples
Presence or absence of small fiber neuropathy obtained after the skin biopsy procedure.
Time frame: Only one biopsy but analysis may take one year.
This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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