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RECRUITINGINTERVENTIONAL

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Inclusion Criteria - 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. Exclusion Criteria -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria * 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. Exclusion Criteria -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Treatments Being Tested

DEVICE

Transcutaneous Electrical Acustimulation (TEA)

TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

DEVICE

Sham-TEA

Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Locations (1)

The University of Texas Health Science Center at Houston
Houston, Texas, United States