Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

The University of Texas Health Science Center, Houston60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Sclerosis Constipation Gastrointestinal Motility Disorder Autonomic Dysfunction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ 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.

Outcomes

Primary Outcomes

Change in slow colonic transit (SCT)

slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion