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Search / Trial NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Aug 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how a treatment called transcutaneous electrical acustimulation (TEA) might help patients with systemic sclerosis (SSc) who also struggle with constipation. The main goal is to see if TEA can improve how the colon and rectum function by enhancing the nervous system's control over these areas. Researchers will look specifically at how TEA affects slow movement in the colon and reduced sensitivity in the rectum, which are common issues for patients with SSc-related constipation.

To participate in this study, you need to be between the ages of 65 and 74 and have constipation related to systemic sclerosis. Participants must have problems like slow colonic transit or rectal hyposensitivity and should not be currently on medication for constipation, or if they are, they must have been on a stable dose for at least a month. Throughout the trial, you can expect to receive TEA treatment and undergo assessments to see how your symptoms change. This study is currently looking for volunteers, and your involvement could help researchers learn more about managing constipation in people with systemic sclerosis.

Gender

ALL

Eligibility criteria

  • 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.

About The University Of Texas Health Science Center, Houston

The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

The University of Texas Health Science Center, Houston

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported