NCT05989763 Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
| NCT ID | NCT05989763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-17 |
| Primary Completion | 2028-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-17 with a primary completion date of 2028-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Zsuzsanna H McMahan, MD, MHS (M-PI)
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05989763 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989763 currently recruiting?
Yes, NCT05989763 is actively recruiting participants. Contact the research team at Zsuzsanna.H.McMahan@uth.tmc.edu for enrollment information.
Where is the NCT05989763 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05989763 clinical trial?
NCT05989763 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Zsuzsanna H McMahan, MD, MHS (M-PI) at The University of Texas Health Science Center, Houston. The trial plans to enroll 60 participants.