Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-26

60

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center, Houston

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with systemic sclerosis-related constipation as defined in the study's first aim
  • Patients with slow colonic transit (more than 20% radiopaque marks remaining in the colon 5 days after swallowing a Sitzmark capsule) or with rectal hyposensitivity
  • Patients not yet receiving treatment for constipation or those on a stable constipation therapy for at least one month prior to TEA treatment
Not Eligible

You will not qualify if you...

  • Patients experiencing both diarrhea and constipation symptoms but without predominant constipation

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

Z

Zsuzsanna H McMahan, MD, MHS (M-PI)

CONTACT

S

Sharvari R Kamat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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