Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

Eligibility criteria

Qualifiers

Patients with SSc-constipation from Aim 1 of the study

Patients with SCT (>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)

Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Transcutaneous Electrical Acustimulation (TEA)
  • Sham-TEA

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator