Status:
RECRUITING
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Systemic Sclerosis
Constipation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05989763
Start Date
February 17 2024
End Date
September 1 2029
Last Update
June 26 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030