NCT05989763Recruiting
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Aug 2023
- Start date
- 17 Feb 2024
- Primary completion date
- 14 Aug 2028
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05989763
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 17 Feb 2024 to the primary completion date, 14 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.